View Clinical Trial (Medical Research Study)
Changes in Insulin Sensitivity After Weight Loss Induced by Diet or Bariatric Surgery
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10032 |
| Conditions: |
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Obesity - Type 2 Diabetes Mellitus - Insulin Resistance |
| Purpose: |
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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.
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| Study Summary: |
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Obesity and weight gain both contribute independently to the development of type 2 diabetes.
Obesity is associated with a pre-diabetic disease state, often called insulin resistance.
Studies have found that some diabetic patients who undergo gastric bypass (GBP) are cured of
their diabetes within 12 weeks after surgery, prior to any significant amount of weight
loss. Since the flow of nutrients from the stomach to the small intestine is interrupted
after GBP, the anatomic modification may cause a greater improvement in insulin sensitivity
than with other forms of weight loss. Changes in levels of hormones released from the
gastrointestinal tract in response to food intake may underlie this increased insulin
sensitivity.
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. Patients who are scheduled for 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, PYY,
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.
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| Criteria: |
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Inclusion Criteria:
- must have diabetes
- adults with diabetes undergoing gastric bypass or sleeve gastrectomy (the study does
not pay for the surgery)
- obese adults with diabetes willing to undergo an inpatient weight loss diet for 2 to
3 weeks
Exclusion Criteria:
- use of triglyceride lowering medication or weight loss medication
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| NCT ID: |
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NCT00627484 |
| Primary Contact: |
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Principal Investigator
Judith Korner, MD,PhD
Columbia University
Gerardo Febres, MD
Phone: 212-342-0281
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| Backup Contact: |
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Email: jk181@columbia.edu
Judith Korner, MD, PhD
Phone: 212 305-3725
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| Location Contact: |
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New York, New York 10032
United States
Gerardo Febres, MD
Phone: 212-342-0281
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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