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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00535600 |
This study, conducted at the NIH Clinical Research Unit (CRU) at the Phoenix Indian Medical Center, will compare the effects of two methods of bariatric surgery, the adjustable BAND and Roux-en-Y gastric bypass, on insulin. Bariatric surgery is a treatment for achieving and maintaining weight loss. The study will look at how this surgery might improve how insulin (a hormone important for regulating blood sugar levels) is made and works in the body and the possible role of changes in other hormones produced by the gut (stomach and intestines).
People between 18 and 50 years of age who are scheduled to have either laparoscopic adjustable BAND or Roux-en-Y gastric bypass surgery may be eligible for this study. Candidates are screened about 4 to 6 weeks before their surgery with a medical history, blood tests and an oral glucose tolerance test for diabetes.
Participants spend 4 days at the CRU or 2 days overnight and an out-patient visit approximately 4 to 6 weeks before their surgery and again 3 to 6 weeks after their surgery. They return for a 4-6 hour visit at the CRU at 6 months, 1 and 2 years after surgery and for half-day outpatient visits at 3, 4 and 5 years after surgery for the following procedures:
Condition |
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Obesity Bariatric Surgery Gastric Bypass Weight Loss Hyperglycemia |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Effects of the Laparoscopic Adjustable BAND Versus Roux-en-Y Gastric Bypass (RYGBP) Surgery on Changes in Insulin Secretion and Insulin Action |
Estimated Enrollment: | 72 |
Study Start Date: | September 2007 |
Bariatric surgery is a treatment for obesity that, in many cases, also improves fasting blood sugar levels even in patients with type 2 diabetes (T2DM) - within days or weeks after sugery. Both inability to use insulin (insulin resistance) and inability to make enough insulin when needed (impaired insulin secretion) must be present for T2DM to occur, and both have been reported to improve after bariatric surgery. It is generally thought that the immediate improvement in blood sugar levels, including remission of T2DM or "prediabetes" in many patients, following bariatric surgery is due to the markedly reduced intake of calories. However, it is not known why blood sugar levels before and after meals tend to improve earlier and to a greater extent in patients who have a Roux-enY gastric bypass (RYGB) procedure than in patients who have the adjustable gastric banding (BAND) procedure. It has been proposed that the surgical alteration of the gut and subsequent re-routing of food that occurs with RYGB procedure results in unique changes in how the gut and pancreas (the organ that secretes insulin) respond to food and that these changes are also related to improved insulin resistance and/or secretion.
The purpose of this protocol is to study, before and after surgery, volunteers who either have normal or impaired ("pre-diabetic") blood sugar regulation and who have been approved to undergo either elective RYGBP or BAND bariatric surgery (n=16 BAND, 16 RYGBP, total = 32 individuals with normal blood sugars; n= 10 BAND, 10 RYGBP, total = 20 individuals with prediabetes). The primary aims are to compare the early effects of the BAND and RYGBP on:
a) the ability to maintain blood sugar levels, b) how much insulin is made (secretion) and works (insulin action) in the body, and c) responses of gut and pancreas hormones to a meal test before any significant weight loss occurs after surgery. To achieve these goals, we initially will screen volunteers at the NIH Clinical Research Unit in Phoenix approximately 4-6 weeks prior to surgery (1-day outpatient visit) to determine oral glucose tolerance status (OGTT). Within 3 weeks (1-4 weeks prior to surgery), subjects will then be admitted (4-day in-patient stay) or a 2 day overnight stay and an outpatient (4-6 hour) visit to measure weight, body fatness (DXA scan), waist circumference, insulin resistance, insulin secretion, fasting blood sugar and hemoglobin A1c (HbA1c; a substance that indicates how well the body keeps overall blood sugar levels in a normal range), and plasma hormone responses of the gut and pancreas to a standard meal test. These measurements will be repeated at 3-6 weeks following surgery.
Secondary aims are to: 1) compare long-term effects (up to 5 years) of BAND vs RYGBP surgery on fasting blood sugar and HbA1c levels, 2) determine if these levels are related to the responses of gut and pancreas hormones during a meal test, and 3) determine whether pre-op or early post-op measures of insulin secretion, insulin action, or responses of gut and pancreas hormones to a meal can predict long-term levels of fasting blood sugar and HbA1c after accounting for changes in weight or body fat. To achieve these goals, subjects will be re-admitted to the NIH CRU (out-patient, 4-6 hour visit) at 6, 12, and 24 months after surgery to have repeat measurements of body weight, fatness (DXA, non-contrast MRI of waist and thigh), waist circumference, fasting blood sugar and HbA1c levels and the gut and pancreatic hormone responses to a meal test. Thereafter, subjects will have annual outpatient measurements of body weight, body fat and fasting blood sugar and HbA1c levels at 3, 4 and 5 years after surgery.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
EXCLUSION CRITERIA:
Because of the indications for bariatric surgery, many potential subjects will have underlying co-morbidities associated with obesity. For this protocol, subjects will be excluded for the following:
Contact: Joy C. Bunt, M.D. | (602) 200-5312 | jbunt@phx.niddk.nih.gov |
United States, Arizona | |
NIDDK, Phoenix | Recruiting |
Phoenix, Arizona, United States, 85014 |
Study ID Numbers: | 999907226, 07-DK-N226 |
Study First Received: | September 25, 2007 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00535600 History of Changes |
Health Authority: | United States: Federal Government |
Bariatric Surgery Insulin Action Insulin Secretion Insulin Resistance Gut Hormones |
Bariatric Surgery Obesity Insulin Resistance Insulin Action |
Obesity Metabolic Diseases Overweight Hormones Insulin Body Weight Signs and Symptoms Hypoglycemic Agents |
Hyperglycemia Weight Loss Body Weight Changes Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder |
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Hyperglycemia Hypoglycemic Agents Weight Loss Body Weight Changes Nutrition Disorders Overnutrition Glucose Metabolism Disorders |