Status:
COMPLETED
Metabolism and Bariatric Surgery Study
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Insulin Resistance
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if diet-induced weight loss causes different changes in hormones that control appetite and glucose control than surgery-induced weight loss. The overall resea...
Detailed Description
Weight loss (WL) improves obesity-related co-morbidities such as type 2 diabetes mellitus (DM). Unfortunately, WL through life-style interventions has a high degree of relapse and the lack of safe, ef...
Eligibility Criteria
Inclusion
- Men and women Ages 18-65 Years Old
Exclusion
- Altered Sleep-wake Cycle
- Type 1 or 2 Diabetes
- Previous Bariatric Surgery
- Lactose Intolerance
- Any Special Diet restrictions.
- Use of medications that may affect body weight at screening or during a 3-month period prior.
- Untreated thyroid disease
- Other medical conditions like Cushing's, acromegaly, Hearth failure, Crohn's disease, etc.
- Pregnancy
- Tobacco or opioid use
- Alcohol dependence
- \> 3% weight change over the 3month period prior to screening
- Unwillingness to maintain current level of physical activity over duration of study period
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03371368
Start Date
October 16 2017
End Date
April 24 2023
Last Update
May 7 2025
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032