Obesity Clinical Trial
Official title:
Physical Inactivity and Insulin Resistance in Skeletal Muscle.
NCT number | NCT00536211 |
Other study ID # | 1095378 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2009 |
Est. completion date | December 2011 |
Verified date | August 2015 |
Source | University of Kansas Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine how a decline in physical activity acutely leads to a decrease in insulin sensitivity in skeletal muscle. The hypothesis is that the loss of insulin sensitivity following physical inactivity is caused by a rapid reduction in skeletal muscle mitochondrial oxidative capacity.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 55 Years |
Eligibility | Inclusion Criteria: - Selection of inclusion for Metabolic Syndrome Subjects : Sedentary metabolic syndrome subjects will be 20-55 y of age, overweight to Class I or II obese (BMI 25-39 kg/m2) men and women, who have a fasting glucose of 100 to 125 mg/dl, and at least 2 of 4 other characteristics of the metabolic syndrome which are the following: waist circumference greater than 102 cm in men and 88 cm in women, serum triglyceride concentration greater than 150 mg/dl, HDL-C concentration greater than 40 mg/dl in men and 50 mg/dl in women, and blood pressure greater than 130/85 mmHG. Selection for inclusion for Endurance Athlete Subjects: Subjects who report training (running and/or biking) greater than 30 min a day, 4 days a week for at least 1 year will be included. Final inclusion criteria will be a VO2max of greater than 55 ml/kg/min. To take part in the study, Women must currently be taking birth control or be postmenopausal. Exclusion Criteria: - Subjects will be excluded from the study if they have or are: Diagnosed cardiovascular disease or diabetes or disease symptoms that could alter their ability to perform exercise, fasting blood glucose of greater than 126 mg/dl, smokers, taking any medications or supplements (e.g., statins, fibrates, metformin, thiazolidinediones, anti-hypertensives (ACE-inhibitors and angiotensin blockers) which could affect blood lipids or insulin sensitivity. Women who are pregnant or plan to become pregnant during the duration of the study For the Metabolic Syndrome subjects only individuals exercising regularly (more than one 30 min session per week) or have a physically active lifestyle (>8,000 daily steps as measured by a pedometer) will be excluded. Individuals with an orthopedic limitations for walking. Allergies to drugs used in the study. Past or current liver and/or kidney problems of any nature. |
Country | Name | City | State |
---|---|---|---|
United States | Harry S. Truman Memorial Veterans' Hospital | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | US Department of Veterans Affairs |
United States,
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Russell AP, Feilchenfeldt J, Schreiber S, Praz M, Crettenand A, Gobelet C, Meier CA, Bell DR, Kralli A, Giacobino JP, Dériaz O. Endurance training in humans leads to fiber type-specific increases in levels of peroxisome proliferator-activated receptor-gamma coactivator-1 and peroxisome proliferator-activated receptor-alpha in skeletal muscle. Diabetes. 2003 Dec;52(12):2874-81. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin sensitivity; following 12 weeks of exercise training and 1 and 3 days of detraining and + or - Metformin. | 12 weeks and 3 days | ||
Secondary | PGC-1 alpha transcription and mitochondrial fatty acid oxidation and enzyme activity in skeletal muscle; following 12 weeks of exercise training and 1, 2, and 3 days of detraining and + or - Metformin. | 12 weeks and 3 days |
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