Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
NCT ID: NCT01780870
Last Updated: 2017-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2012-09-30
2017-01-31
Brief Summary
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The investigators will also study the following:
1. The impact of diet induced weight loss on hormones/adipokine levels
2. The impact of diet induced weight loss on leptin tolerance
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Control Group
Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
No interventions assigned to this group
Weight loss group
Full Meal replacement Protocol
Weight loss group (Full meal replacement products)
In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase
Interventions
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Weight loss group (Full meal replacement products)
In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. English speaking
3. Body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2
4. Willing to enroll in a low calorie full meal replacement weight loss program
5. Willing and able to take part in a multi year study involving visits
1. Adult men and women, age 18-50
2. English speaking
3. Body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2
4. Willing and able to take part in a multi year study involving visits
18 Years
50 Years
ALL
Yes
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Christos Mantzoros
Professor of Medicine
Principal Investigators
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Christos Mantzoros, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2011P000293
Identifier Type: -
Identifier Source: org_study_id
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