NCT00399360|CompletedResultsDMC
Lifestyle Modification and Metformin Use in the Treatment of HIV
Strategies for the Treatment of HIV Associated Metabolic Syndrome
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Sponsor study identifier
Secondary identifiers
NIH
interventional
50
1 country
1
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2011
Actual (reported)Study Completion
June 2012
Actual (reported)A healthy diet and exercise have improved the health of people without human immunodeficiency virus (HIV) who have Metabolic Syndrome. In this study we would like to find out if the same benefit can be seen in people with HIV and Metabolic Syndrome. Patients with Metabolic Syndrome usually have a large waist, high blood cholesterol levels, high blood pressure, and high blood sugar levels. These are risk factors, which may increase one's chance of developing heart disease and/or diabetes. The purpose of the study is to evaluate the effects of different methods of treating HIV associated Metabolic Syndrome. The groups are: 1) a lifestyle modification program plus metformin (also known as glucophage), 2) lifestyle modification plus placebo, 3) metformin alone or 4) placebo alone. The lifestyle modification program consists of nutrition and exercise sessions with the goal of improving body composition, heart health, and ways to lower the risk of developing diabetes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 13, 2006
Actual (reported)November 14, 2006
Actual (reported)December 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 2011
Actual (reported)June 2012
Actual (reported)September 14, 2012
Actual (reported)Carotid Intima Media Thickness
Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.
baseline and 12 months
Waist Circumference
Iliac waist circumference measurements were obtained using an inelastic tape measure. All measurements were obtained in triplicate, with the patient undressed, and then averaged. The change of the waist circumference measurement between baseline and 12 months is reported.
baseline and 12 months
High Density Lipoprotein (HDL)
High density lipoprotein (HDL) was determined after an overnight fast. The change in HDL between baseline and 12 months is reported.
baseline and 12 months
Glucose
C-reactive Protein
baseline and 12 months
Abdominal Visceral Adiposity
baseline and 12 months
Cardiorespiratory Fitness
baseline and 12 months
Intramyocellular Lipid
baseline and 12 months
No Lifestyle Modification and Placebo
Lifestyle Modification and Placebo
No Lifestyle Modification and Metformin
Starting at 500 mg twice daily and increasing to 850 mg twice daily after 3 Months
500 mg twice daily increasing to 850 mg twice daily after 3 Months
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Fitch K, Abbara S, Lee H, Stavrou E, Sacks R, Michel T, Hemphill L, Torriani M, Grinspoon S. Effects of lifestyle modification and metformin on atherosclerotic indices among HIV-infected patients with the metabolic syndrome. AIDS. 2012 Mar 13;26(5):587-97. doi: 10.1097/QAD.0b013e32834f33cc.
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.
Steven K. Grinspoon, MD
Massachusetts General Hospital
50 participants (actual enrollment reported by the registry).
First Submitted
November 13, 2006
First Posted
November 14, 2006
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study of TNF-Antagonism in Metabolic Syndrome
Glucose level was determined after an overnight fast. The change in glucose between baseline and 12 months is reported.
baseline and 12 months
Systolic Blood Pressure
Systolic blood pressure was measured after 5 minutes rest. The in systolic blood pressure between baseline and 12 months is reported.
baseline and 12 months
Coronary Artery Calcium Score
Computed tomography (CT) imaging was performed using a SOMATOM Sensation (Siemens Medical Solutions, Forcheim, Germany) 64-slice CT scanner. Agatston calcium score was calculated using CT images. The total Agatston score is calculated by summing up the scores of the individual calcifications in all slices of the CT scan. An absolute Agatston score of less than 10 indicates minimal overall atherosclerosis (plaques) in the coronary arteries. The change in the coronary artery calcium score between baseline and 12 months is reported.
baseline and 12 months
Lifestyle Modification and Metformin
Lifestyle Modification
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Primary Completion
June 2011
Actual (reported)Study Completion
June 2012
Actual (reported)Last Updated
September 14, 2012
Results First Posted
September 14, 2012
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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