Lifestyle Modification and Metformin Use in the Treatment of HIV

This study has been completed.

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

Steven K. Grinspoon, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00399360

First received: November 13, 2006

Last updated: September 13, 2012

Last verified: September 2012

History of Changes

Results First Received: May 18, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	HIV Infections Metabolic Syndrome X
Interventions:	Drug: Metformin Drug: Placebo Behavioral: Lifestyle Modification

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
No Lifestyle Modification and Placebo	Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Placebo	Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
No Lifestyle Modification and Metformin	Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Metformin	Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.

Participant Flow: Overall Study

	No Lifestyle Modification and Placebo	Lifestyle Modification and Placebo	No Lifestyle Modification and Metformin	Lifestyle Modification and Metformin
STARTED	11	11	13	15
COMPLETED	9	8	10	9
NOT COMPLETED	2	3	3	6
Lost to Follow-up	2	1	2	4
Adverse Event	0	0	1	0
Withdrawal by Subject	0	2	0	2

Baseline Characteristics

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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.
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Reporting Groups

	Description
No Lifestyle Modification and Placebo	Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Placebo	Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
No Lifestyle Modification and Metformin	Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Metformin	Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Total	Total of all reporting groups

Baseline Measures

	No Lifestyle Modification and Placebo	Lifestyle Modification and Placebo	No Lifestyle Modification and Metformin	Lifestyle Modification and Metformin	Total
Overall Participants Analyzed [Units: Participants]	11	11	13	15	50

Age [Units: Participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	11	11	13	15	50
>=65 years	0	0	0	0	0

Age [Units: Years] Mean (Standard Deviation)	47 (6)	49 (8)	45 (9)	47 (8)	47 (7)

Gender [Units: Participants]
Female	4	3	3	2	12
Male	7	8	10	13	38

Race (NIH/OMB) [Units: Years]
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	4	4	3	5	16
White	7	6	9	10	32
More than one race	0	0	0	0	0
Unknown or Not Reported	0	1	0	0	1

Region of Enrollment [Units: Participants]
United States	11	11	13	15	50

Outcome Measures

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1. Primary:

Carotid Intima Media Thickness [ Time Frame: baseline and 12 months ]

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2. Primary:

Waist Circumference [ Time Frame: baseline and 12 months ]

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3. Primary:

High Density Lipoprotein (HDL) [ Time Frame: baseline and 12 months ]

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4. Primary:

Glucose [ Time Frame: baseline and 12 months ]

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5. Primary:

Systolic Blood Pressure [ Time Frame: baseline and 12 months ]

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6. Primary:

Coronary Artery Calcium Score [ Time Frame: baseline and 12 months ]

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7. Secondary:

C-reactive Protein [ Time Frame: baseline and 12 months ]

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8. Secondary:

Abdominal Visceral Adiposity [ Time Frame: baseline and 12 months ]

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9. Secondary:

Cardiorespiratory Fitness [ Time Frame: baseline and 12 months ]

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10. Secondary:

Intramyocellular Lipid [ Time Frame: baseline and 12 months ]

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Serious Adverse Events

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Time Frame	12 months
Additional Description	safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked

Reporting Groups

	Description
No Lifestyle Modification and Placebo	Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Placebo	Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
No Lifestyle Modification and Metformin	Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Metformin	Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.

Serious Adverse Events

	No Lifestyle Modification and Placebo	Lifestyle Modification and Placebo	No Lifestyle Modification and Metformin	Lifestyle Modification and Metformin
Total, Serious Adverse Events
# participants affected / at risk	0/11 (0.00%)	0/11 (0.00%)	0/13 (0.00%)	0/15 (0.00%)

Other Adverse Events

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Limitations and Caveats

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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
The study was relatively small and may have been underpowered to assess effect on secondary endpoints and to assess the effects of lifestyle modification. The sample size may have limited our ability to determine differences in dropout rates.

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