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Trial record 16 of 76 for:    Long-chain fatty acids

Fatty Acid Oxidation Disorders & Body Weight Regulation Grant

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ClinicalTrials.gov Identifier: NCT00654004
Recruitment Status : Completed
First Posted : April 7, 2008
Results First Posted : April 22, 2013
Last Update Posted : April 22, 2013
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oregon State University
Information provided by (Responsible Party):
Melanie B Gillingham, Oregon Health and Science University

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition Trifunctional Protein Deficiency
Enrollment 26
Recruitment Details Subjects with a long-chain fatty acid oxidation disorder were recruited through announcements on disease specific websites, and referrals from metabolic physicians. Controls were recruited through the OHSU website and word of mouth.
Pre-assignment Details After a subject had completed the protocol, potential control subjects were screened for age, gender and BMI that would allow for a 1 to 1 matching study design.
Arm/Group Title Subjects Controls
Hide Arm/Group Description Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency. Subjects do not have a fatty acid oxidation disorder.
Period Title: Overall Study
Started 14 12
Completed 13 12
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Subjects Controls Total
Hide Arm/Group Description Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency. Subjects do not have a fatty acid oxidation disorder. Total of all reporting groups
Overall Number of Baseline Participants 14 12 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
<=18 years
11
  78.6%
10
  83.3%
21
  80.8%
Between 18 and 65 years
3
  21.4%
2
  16.7%
5
  19.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 26 participants
14  (8) 15  (7) 14.3  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
Female
6
  42.9%
5
  41.7%
11
  42.3%
Male
8
  57.1%
7
  58.3%
15
  57.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
United States 12 12 24
Canada 1 0 1
Europe 1 0 1
1.Primary Outcome
Title An Outcome of This Study is the Difference in Percent Body Fat (%BF) Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.
Hide Description Body composition by DEXA was measured in subjects with a long-chain fatty acid oxidation disorder (n=13). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed body composition measures. The difference in body composition between subjects and age matched controls was compared by t-test.
Time Frame Subjects will be compared to controls at one point in time.
Hide Outcome Measure Data
Hide Analysis Population Description
Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.
Arm/Group Title Subjects Controls
Hide Arm/Group Description:
Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
Subjects do not have a fatty acid oxidation disorder.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: percentage of body fat
31.8  (6.8) 27.2  (9.1)
2.Primary Outcome
Title An Outcome of This Study is the Difference in Glucose Tolerance Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.
Hide Description

Glucose tolerance was estimated by the Matsuda Index using glucose and insulin values from a standard oral glucose tolerance test. The Matsuda Index is calculated by the following formula: 10,000/ sq root of (fasting glucose mg/dl X fasting insulin in units/ml) X (mean glucose (mg/dl) X mean insulin (units/ml) and correlates with insulin sensitivity measured by the gold standard method of a hyperinsulinemic euglycemic clamp. Values of 2.5 or greater are considered insulin sensitive. Values of 2.4 or less are considered insulin resistance.

The Matsuda Index of Insulin Sensitivity was measured in subjects with a long-chain fatty acid oxidation disorder (n=12). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed an oral glucose tolerance test. The difference in Mastuda Index between subjects and age matched controls was compared by t-test.

Time Frame Subjects will be compared to controls at one point in time.
Hide Outcome Measure Data
Hide Analysis Population Description
Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.
Arm/Group Title Subjects Controls
Hide Arm/Group Description:
Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
Subjects do not have a fatty acid oxidation disorder.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.8  (1.8) 3.13  (1.57)
3.Secondary Outcome
Title The Difference in Plasma Adiponectin Levels Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test
Hide Description Fasting total adiponectin levels in ug/ml were measured in both groups (subjects with a long-chain fatty acid oxidation disorder). The differences between groups were compared with a t-test
Time Frame Fasting total adiponectin (ug/ml)
Hide Outcome Measure Data
Hide Analysis Population Description
Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.
Arm/Group Title Subjects Controls
Hide Arm/Group Description:
Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
Subjects do not have a fatty acid oxidation disorder.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ug/ml
17.3  (7.2) 24.4  (13.5)
4.Secondary Outcome
Title The Difference in Plasma Leptin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test
Hide Description Fasting leptin in ng/kg fat mass were measured in both groups (subjects with a long-chain fatty acid oxidation disorder; controls). The differences between groups were compared with a t-test
Time Frame Fasting leptin levels ng per kg of fat mass
Hide Outcome Measure Data
Hide Analysis Population Description
Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.
Arm/Group Title Subjects Controls
Hide Arm/Group Description:
Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
Subjects do not have a fatty acid oxidation disorder.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng/kg
0.99  (0.8) 0.91  (0.57)
5.Secondary Outcome
Title The Difference in Plasma Insulin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test
Hide Description Fasting insulin levels in uU/ml were measured in both groups. The differences between groups were compared with a t-test
Time Frame Fasting insulin levels uUnits/ml
Hide Outcome Measure Data
Hide Analysis Population Description
Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. Samples were missing on one subject so 11 subjects were compared to 11 controls.
Arm/Group Title Subjects Controls
Hide Arm/Group Description:
Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
Subjects do not have a fatty acid oxidation disorder.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: uU/ml
17  (8) 13  (5)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were assessed during the study. No serious adverse events occurred during the study.
 
Arm/Group Title Subjects Controls
Hide Arm/Group Description Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency. Subjects do not have a fatty acid oxidation disorder.
All-Cause Mortality
Subjects Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subjects Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Subjects Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Trial included small number of subjects with a rare disorder of long-chain fatty acid oxidation. Subjects were predominately children and adolescents. There were some technical difficulties with recruitment and collection of all the outcomes.
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.
Results Point of Contact
Name/Title: Dr. Melanie Gillingham
Organization: Oregon Health & Science Univeristy
Phone: 503-494-1682
Responsible Party: Melanie B Gillingham, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00654004     History of Changes
Other Study ID Numbers: DK71869
K01DK071869 ( U.S. NIH Grant/Contract )
First Submitted: April 3, 2008
First Posted: April 7, 2008
Results First Submitted: December 11, 2012
Results First Posted: April 22, 2013
Last Update Posted: April 22, 2013