Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients

This study has been completed.

Sponsor:

Collaborators:

National Institutes of Health (NIH)

Merck

Information provided by (Responsible Party):

Warren K Bolton, University of Virginia

ClinicalTrials.gov Identifier:

NCT00395291

First received: November 1, 2006

Last updated: November 30, 2011

Last verified: November 2011

History of Changes

Results First Received: August 2, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Chronic Kidney Disease End Stage Renal Disease
Intervention:	Drug: MK-0677

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We recruited our subjects from 3 clinics at the University of Virginia. Our clinics were located at the Dialysis Units in Charlottesville, VA, Fisherville, VA, and Zion Crossroads, VA. Subjects were recruited into this study between March 2007 and August 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
49 Subjects were recruited; 26 Subjects started intervention (4 Subjects started study intervention and then were dropped from the study), 22 Subjects Completed this trial. 1 Subject withdrew their consent prior to study intervention. 22 Subjects did not meet inclusion/exclusion criteria.

Reporting Groups

	Description
MK-0677 First, Then Placebo	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo First, Then MK-0677	Subjects took Placebo for at least 30 days.

Participant Flow for 3 periods

Period 1: First Intervention

	MK-0677 First, Then Placebo	Placebo First, Then MK-0677
STARTED	17	9
COMPLETED	15	9
NOT COMPLETED	2	0

Period 2: Washout Period for 30 Days

	MK-0677 First, Then Placebo	Placebo First, Then MK-0677
STARTED	15	9
COMPLETED	13	9
NOT COMPLETED	2	0

Period 3: Second Intervention

	MK-0677 First, Then Placebo	Placebo First, Then MK-0677
STARTED	13	9
COMPLETED	13	9
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Entire Study Population	Includes groups randomized to placebo first and MK-0677 first.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	26
Age [units: participants]
<=18 years	0
Between 18 and 65 years	18
>=65 years	8
Age [units: years] Mean ± Standard Deviation	57.3 ± 14.4
Gender [units: participants]
Female	8
Male	18
Region of Enrollment [units: participants]
United States	26

Outcome Measures

Hide All Outcome Measures

1. Primary:

Change in IGF-1 After 30 Days of Intervention [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Primary
Measure Title	Change in IGF-1 After 30 Days of Intervention
Measure Description	Change in IGF-1 after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 Subjects completed both interventions and lab results were available.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	22
Change in IGF-1 After 30 Days of Intervention [units: ng/ml] Mean ± Standard Deviation	92.7 ± 62.3	6.7 ± 40.2

Statistical Analysis 1 for Change in IGF-1 After 30 Days of Intervention

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in IGF-1 is the same for both the MK-0677 and placebo interventions. Power calculation: We assumed that the IGF-I data will be lognormally distributed and thus the parameter of interest will be the IGF-1 geometric mean. If n=22 individuals complete the study and the intervention effect is 48% greater for one intervention than the other we will have at least 0.80 power to reject the null hypothesis.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The IGF-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.

2. Secondary:

Change in the Following Level: Acyl-Ghrelin [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Change in the Following Level: Acyl-Ghrelin
Measure Description	Change in Acyl-Ghrelin after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects completed both interventions.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	22
Change in the Following Level: Acyl-Ghrelin [units: pg/ml] Mean ± Standard Deviation	-23.4 ± 68.9	3.5 ± 150.3

Statistical Analysis 1 for Change in the Following Level: Acyl-Ghrelin

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.169

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in Acyl-Ghrelin is the same for both the MK-0677 and placebo interventions. Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The Acyl-Ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

3. Secondary:

Change in the Following Level: Leptin [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Change in the Following Level: Leptin
Measure Description	Change in Leptin after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects completed both interventions.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	22
Change in the Following Level: Leptin [units: ng/ml] Mean ± Standard Deviation	24.4 ± 50.2	-6.9 ± 30.4

Statistical Analysis 1 for Change in the Following Level: Leptin

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.063

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in leptin is the same for both the MK-0677 and placebo interventions. Because Leptin is considered a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The Leptin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

4. Secondary:

Change in the Following Level: Insulin [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Change in the Following Level: Insulin
Measure Description	Change in Insulin after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects completed both interventions.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	22
Change in the Following Level: Insulin [units: uIU/ml] Mean ± Standard Deviation	3.77 ± 10.5	-.2 ± 12.5

Statistical Analysis 1 for Change in the Following Level: Insulin

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.075

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in serum-insulin is the same for both the MK-0677 and placebo interventions. Because serum-insulin is considered a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The insulin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

5. Secondary:

Changes in the Following Level: Des-Acyl-Ghrelin [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Changes in the Following Level: Des-Acyl-Ghrelin
Measure Description	Change in Des-Acyl-Ghrelin after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 Subjects completed both interventions.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	22
Changes in the Following Level: Des-Acyl-Ghrelin [units: pg/ml] Mean ± Standard Deviation	30.2 ± 201.5	-44.05 ± 157.4

Statistical Analysis 1 for Changes in the Following Level: Des-Acyl-Ghrelin

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	.782

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

6. Secondary:

Changes in the Following Level: TNF-alpha [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Changes in the Following Level: TNF-alpha
Measure Description	Change in TNF-alpha after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	21
Changes in the Following Level: TNF-alpha [units: pg/ml] Mean ± Standard Deviation	1.2 ± 5.9	-0.7 ± 14.6

Statistical Analysis 1 for Changes in the Following Level: TNF-alpha

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.385

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in TNF-a is the same for both the MK-0677 and placebo interventions. Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The TNF-a data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

7. Secondary:

Changes in the Following Level: CRPs [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Changes in the Following Level: CRPs
Measure Description	Change in CRPs after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 Subjects completed both interventions.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	22
Changes in the Following Level: CRPs [units: mg/ml] Mean ± Standard Deviation	2.6 ± 13.4	6.0 ± 32.7

Statistical Analysis 1 for Changes in the Following Level: CRPs

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.929

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in CRPs is the same for both the MK-0677 and placebo interventions. Because CRPs is considered as a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The CRPs data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

8. Secondary:

Changes in the Following Level: IL-1 [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Changes in the Following Level: IL-1
Measure Description	Change in IL-1 after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	21
Changes in the Following Level: IL-1 [units: pg/ml] Mean ± Standard Deviation	0.0 ± 0.2	-0.0 ± 0.3

Statistical Analysis 1 for Changes in the Following Level: IL-1

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.905

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-1 is the same for both the MK-0677 and placebo interventions. Because IL-1 is considered as a secondary outcome, no power analysis was conducted
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The IL-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

9. Secondary:

Changes in the Following Level: IL-6 [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Changes in the Following Level: IL-6
Measure Description	Change in IL-6 after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	21
Changes in the Following Level: IL-6 [units: pg/mL] Mean ± Standard Deviation	3.1 ± 5.2	0.8 ± 6.9

Statistical Analysis 1 for Changes in the Following Level: IL-6

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.233

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

10. Secondary:

Changes in the Following Level: IL-10 [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Changes in the Following Level: IL-10
Measure Description	Change in IL-10 after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	21
Changes in the Following Level: IL-10 [units: pg/ml] Mean ± Standard Deviation	-0.1 ± 1.9	0.7 ± 1.7

Statistical Analysis 1 for Changes in the Following Level: IL-10

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.277

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-10 is the same for both the MK-0677 and placebo interventions. Because IL-10 is considered as a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The IL-10 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

11. Secondary:

Changes in the Following Level: Esterase [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Changes in the Following Level: Esterase
Measure Description	Change in Esterase after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects completed both interventions and results were available.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	22
Changes in the Following Level: Esterase [units: units/ml] Mean ± Standard Deviation	-1.6 ± 10.3	-1.3 ± 12.6

Statistical Analysis 1 for Changes in the Following Level: Esterase

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.875

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in esterase is the same for both the MK-0677 and placebo interventions. Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The esterase data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

12. Secondary:

Changes in the Following Level: Adiponectin [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Changes in the Following Level: Adiponectin
Measure Description	Change in Adiponectin after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	21
Changes in the Following Level: Adiponectin [units: ng/ml] Mean ± Standard Deviation	1242.0 ± 7858.1	735.1 ± 4485.0

Statistical Analysis 1 for Changes in the Following Level: Adiponectin

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.545

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in adiponectin is the same for both the MK-0677 and placebo interventions. Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The adiponectin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

13. Secondary:

Change in the Following Level: Total Ghrelin [ Time Frame: After the subject has comleted their last visit ]

Measure Type	Secondary
Measure Title	Change in the Following Level: Total Ghrelin
Measure Description	Change in Total Ghrelin after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects completed both interventions and lab results were available for all 22.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	22
Change in the Following Level: Total Ghrelin [units: pg/ml] Mean ± Standard Deviation	6.9 ± 162.5	-40.5 ± 192.5

Statistical Analysis 1 for Change in the Following Level: Total Ghrelin

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.900

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in Total-Ghrelin is the same for both the MK-0677 and placebo interventions. Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Total ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We completed the appropriate number of subjects to get the statistical data needed. We had several screen fails (subjects that did not meet the inclusion/exclusion criteria.)

Results Point of Contact:

Name/Title: W. Kline Bolton, MD
Organization: University of Virginia
phone: 434-924-9692
e-mail: wkb5s@Virginia.edu

No publications provided

Responsible Party:	Warren K Bolton, University of Virginia
ClinicalTrials.gov Identifier:	NCT00395291 History of Changes
Other Study ID Numbers:	12569
Study First Received:	November 1, 2006
Results First Received:	August 2, 2011
Last Updated:	November 30, 2011
Health Authority:	United States: Food and Drug Administration

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