View Clinical Trial (Medical Research Study)
Progressive Weight Loss and Metabolic Health
| City: |
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Saint Louis |
| State: |
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Missouri |
| Zip Code: |
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63110 |
| Conditions: |
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Insulin Resistance - Obesity |
| Purpose: |
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The investigators are looking to see if weight loss will result in decreased deposits of fat
in the body (total body fat, abdominal fat, liver fat, fat in the muscle) and an improvement
of energy production by the muscle. The investigators also are looking to see if weight loss
will lead to improved sugar metabolism and cardiovascular health, change in the
microorganisms that are present in the intestine, and decreased body temperature. The
investigators are looking to see if weight loss will improve the way the brain functions,
and also the brain's structure.
The investigators also are looking to see if greater amounts of weight loss will lead to
greater improvements for each variable or if the minimum weight loss threshold for achieving
a beneficial effect will be different for the different parts of the body.
This will provide important information that will help optimize diets to achieve the most
favourable health benefits and potentially provide new insights into obesity related
metabolic abnormalities such as diabetes and cardiovascular disease.
If you are enrolled in this study, you will be randomly assigned (by chance, like the flip
of a coin) to one of 2 groups. Group 1: supervised weight loss group (low-calorie diet).
Group 2: supervised weight maintenance group (normal diet).
After testing at the beginning of the study: Group 1 will lose 5%, 10%, and 15% of their
weight over time under the guidance of a dietitian. The investigators expect the complete
weight loss to require approximately one year. Research testing will be repeated at each
time point. Group 2 will maintain their weight. Research testing will be repeated after six
months.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Obese: Body Mass Index from 30 to 45
- Insulin Resistant: HOMA-IR score greater than 3
Exclusion Criteria:
- diabetes
- smoking
- pregnancy
- breastfeeding
- heart failure
- history of liver disease including hepatitis
- alcoholism
- exercise more than one hour per week
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| NCT ID: |
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NCT01299519 |
| Primary Contact: |
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Principal Investigator
Samuel Klein, MD
Washington University School of Medicine
Emily Jenkerson, B.A.
Phone: 314-362-1000
Email: jenkersone@wustl.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Saint Louis, Missouri 63110
United States
Emily Jenkerson
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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