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Changes in Insulin Sensitivity After Weight Loss

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ClinicalTrials.gov Identifier: NCT00627484
Recruitment Status : Active, not recruiting
First Posted : March 3, 2008
Last Update Posted : December 11, 2017
Information provided by (Responsible Party):

Study Description
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. The main hypothesis of this study is that weight loss induced by gastric bypass will induce a greater improvement in insulin sensitivity compared with gastric banding or low calorie diet. Subjects will be studied before and after weight loss. Studies consist of intravenous glucose tolerance test, body composition analysis, meal test, and energy expenditure.

Condition or disease Intervention/treatment
Obesity Type 2 Diabetes Mellitus Insulin Resistance Procedure: Gastric bypass Procedure: Gastric banding Procedure: Sleeve gastrectomy Behavioral: Very low calorie diet

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 weight, and when 6-10% total body weight has been lost. We will measure insulin sensitivity with an intravenous glucose tolerance test, and fasting levels of hormones that regulate food intake and insulin sensitivity, such as ghrelin, peptide YY (PYY), glucagon-like peptide 1 (GLP1) and leptin. Fat mass and skeletal muscle mass will be measured by dual photon absorptiometry (DXA). We will also measure the hormonal and thermic response to food with a liquid test meal and energy expenditure by indirect calorimetry. This measures how many calories are burned at rest and the in response to food. Subjects with diabetes will continue to be studied with the same protocol on an annual basis out to 5 years in order to determine the rate of remission of diabetes and the durability of this effect as subjects tend to regain some body weight over time.

Subjects with diabetes will also be followed every three months for the first year after the initial weight loss for HbA1c and fasting glucose levels. The results of this study may lead to new understanding about changes in insulin sensitivity, body composition and hormonal profile, as well as changes in energy expenditure with weight loss after bariatric surgery or with simple caloric restriction. With this greater understanding, new treatments for obesity and diabetes, that do not require surgery, may be developed.

Study Design

Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Changes in Insulin Sensitivity After Weight Loss Induced by Diet or Bariatric Surgery
Actual Study Start Date : March 1, 2005
Primary Completion Date : September 1, 2017
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1: GBP non-diabetic
Non-diabetic subjects scheduled to receive gastric bypass
Procedure: Gastric bypass
NOTE: the surgery is not paid for by the study
Other Name: GBP
Group 2: BND non-diabetic
Non-diabetic subjects scheduled to receive gastric banding
Procedure: Gastric banding
NOTE: the surgery is not paid for by the study
Other Name: BND
Group 3: GBP diabetic
Diabetic subjects scheduled to receive gastric bypass
Procedure: Gastric bypass
NOTE: the surgery is not paid for by the study
Other Name: GBP
Group 4: VLCD diabetic
Diabetic subjects scheduled to receive very low calorie diet
Behavioral: Very low calorie diet
Weight loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time.
Other Name: VLCD
Group 5: SG diabetic
Diabetic subjects scheduled to receive sleeve gastrectomy
Procedure: Sleeve gastrectomy
NOTE: the surgery is not paid for by the study
Other Name: SG

Outcome Measures

Primary Outcome Measures :
  1. Change in Insulin Sensitivity [ Time Frame: 2-8 weeks ]
    Measured by frequently sampled intravenous glucose tolerance test (FSIVGTT)

Secondary Outcome Measures :
  1. Change in Body Composition [ Time Frame: 2-8 weeks ]
    Measured by dual energy x-ray absorptiometry (DXA)

  2. Change in Resting Energy Expenditure [ Time Frame: Up to 4 hrs post-meal ]
    Measured by indirect calorimetry using a Hood Calorimeter

Biospecimen Retention:   Samples With DNA
The researchers may want to retain your blood and/or tissue sample(s) so that additional research studies can be done now or in the future.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects will be recruited by physician referral and from outpatient obesity, bariatric surgical clinics and endocrinology clinics at Columbia University Medical Center as well as from the Medical Center Community and metropolitan area via IRB-approved flyers and internet postings. Subjects will also be recruited from the following website: www.craigslist.com using the same posting format of the IRB-approved flyers.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627484

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Judith Korner, MD,PhD Columbia University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judith Korner, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00627484     History of Changes
Other Study ID Numbers: AAAB2401
R21DK081050 ( U.S. NIH Grant/Contract )
DK072011 ( Other Grant/Funding Number: NIDDK )
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Judith Korner, Columbia University:
Insulin resistance
Insulin sensitivity
bariatric surgery
calorie restriction
body composition

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Weight Loss
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs