Status:
COMPLETED
Changes in Insulin Sensitivity After Weight Loss
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Brief Summary
This study is designed to compare the changes in insulin sensitivity as well as gastrointestinal hormone levels in diabetic and non-diabetic obese individuals who are undergoing weight loss procedures...
Detailed Description
Patients who are scheduled for gastric bypass (GBP), sleeve gastrectomy (SG), or simple caloric restriction with gastric banding (BND) or a very low calorie diet (VLCD) will be examined at baseline we...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Non-diabetic obese (BMI \> 30) adult men and women between the ages of 18 and 75 scheduled to undergo
- gastric bypass (GBP)
- gastric banding (BND)
- Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 75 scheduled to undergo gastric bypass.
- Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 65 for weight reduction with a very low caloric diet (VLCD).
- Type 2 diabetes mellitus scheduled to undergo sleeve gastrectomy (SG).
- Exclusion criteria:
- Pregnancy.
- Age \> 75 for surgery groups; Age \> 65 for VLCD group.
- Treatment with glucocorticoids, anti-depressants, anti-psychotics, neuroleptics, weight loss medications, experimental medication.
- Greater than a 5% change in total body weight in the 90 days prior to the study.
- History of untreated gallstones; hepatic or renal insufficiency, abnormal thyroid stimulating hormone (TSH).
- Use of thiazolidinedione therapy.
- HbA1c \> 12%.
- Use of dipeptidyl peptidase IV (DPP-IV) inhibitor or glucagon-like peptide 1 receptor (GLP-1R) agonist for greater than 12 months within 3 months of the study.
- Fasting triglycerides \> 400.
- Significant cardiovascular, neurologic, renal, gastrointestinal, or hematologic disease.
- Inability to comply with or understand the study protocol as ascertained by the PI.
- We will not exclude individuals with body weight \> 145 kg, but we do recognize that such individuals are above the table weight limitations of the dual-energy x-ray absorptiometry (DEXA) scan and body composition data will be unavailable for those individuals.
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 17 2018
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00627484
Start Date
March 1 2005
End Date
June 17 2018
Last Update
September 19 2019
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032