Obesity Clinical Trial
Official title:
Effects of Caloric Restriction Alone Versus Postoperative Caloric Restriction Following Bariatric Surgery on Glucose Metabolism in Patients With Diabetes Mellitus
Verified date | December 13, 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background:
- Bariatric surgery is the most effective way to achieve significant, long-term weight
loss. It has also been shown to be an effective therapy for obese individuals with type
2 diabetes: more than 70 percent of patients no longer need medications for diabetes
after surgery. This resolution of diabetes is predominately caused by marked weight loss
resulting in improved insulin sensitivity. However, the beneficial effects of bariatric
surgery on type 2 diabetes cannot be accounted for entirely by weight loss, because many
bariatric surgery patients have resolution of diabetes within 1 week following bariatric
surgery, even before they lose a clinically significant amount of weight.
- One possible reason for the rapid resolution of diabetes after bariatric surgery .is
that during the first week after surgery, patients can eat very little (about 300
Calories per day). It is well known that reducing calories to this level improves
diabetes. Another possibility is that changes in the flow of food through the intestines
may improve diabetes. Evidence for this comes from the observation that patients after
gastric bypass have better glucose levels than those who have gastric banding.
Researchers are interested in determining how much of the improvement in diabetes in the
first week after Roux-en-Y gastric bypass (RYGBP) surgery is due to restricting
calories, and how much is due to other factors, such as bypassing the upper part of the
small intestine.
Objectives:
- To determine the change in total body insulin sensitivity after RYGBP compared to
caloric restriction without surgery.
- To study possible reasons for improvements in diabetes after RYGBP.
Eligibility:
- Individuals 18 to 60 years of age who have a body mass index (BMI) greater than 35 and have
type 2 diabetes.
Design:
- This is not a randomized study, and patients will not receive bariatric surgery as part of
this study.
Two groups of patients will be studied: those scheduled for RYGBP surgery and those not
undergoing surgery.
- RYGBP Surgery Participants:
- Up to 3 weeks before surgery, participants will spend 2 nights and days at the
Vanderbilt University Clinical Research Center or the NIH Clinical Center for testing to
learn about how their bodies handle sugar and use energy. During the 5 days prior to
these tests, participants will be asked to not take diabetes medications, and will check
blood sugar at least twice a day.
- From 8 days before surgery, participants will begin an 800 Calorie per day liquid diet
to prepare for surgery.
- After surgery and discharge, participants will be readmitted to the Clinical Research
Center at Vanderbilt or NIH for further tests and diet monitoring. Diabetes medications
may be adjusted or stopped altogether based on the results of the tests.
- Non-surgery Participants:
- Participants will spend 2 nights and days in the NIH Clinical Center for testing to
learn about how their bodies handle sugar and use energy. During the 5 days prior to
these tests, participants will be asked to not take diabetes medications, and will check
blood sugar at least twice a day.
- After the tests, participants will begin an 800 Calorie per day liquid diet for 8 days.
- After 8 days, participants will be readmitted to the Clinical Center at NIH for 1 week
of further tests and a 300 Calorie per day diet. Diabetes medications may be adjusted or
stopped altogether based on the results of the tests.
Status | Terminated |
Enrollment | 5 |
Est. completion date | December 13, 2019 |
Est. primary completion date | May 22, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
- INCLUSION CRITERIA: 1. Clinical diagnosis of Type 2 diabetes mellitus 2. Age 18-60 years 3. Body mass index greater than or equal to 35 kg/m(2) 4. Either --a. Patients scheduled for Roux-en-Y gastric bypass at Vanderbilt University Medical Center or University of Maryland OR --b. Patients matched for race, sex, BMI (plus or minus 15%), and age (plus or minus 5 years) to RYGBP patients, above, but NOT scheduled for bariatric surgery. 5. Subjects must have an endocrinologist or primary care provider who manages their diabetes. EXCLUSION CRITERIA: 1. Current use of insulin 2. Use of exenatide, sitagliptin (or other dipeptidyl peptidase inhibitor), thiazolidinediones, or experimental diabetes medication within the past 3 months 3. Medical condition that alters glucose metabolism (other than type 2 diabetes) or weight (e.g. chronic inflammatory diseases, monogenic obesity, Prader-Willi syndrome) 4. Current use of medication that alters glucose metabolism (other than oral diabetes medications) or weight (e.g. corticosteroids, atypical antipsychotic drugs) 5. Significant comorbidity that, in the opinion of the investigators, will increase risk to the subject, (e.g. current treatment for cancer, renal failure) 6. Positive urine pregnancy test or plans to become pregnant during the clinical trial 7. Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures 8. Body weight greater than 450 lbs 9. History of previous bariatric surgical procedure or other surgery altering the length or arrangement of the intestines (e.g. Whipple procedure) |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland, Baltimore | Baltimore | Maryland |
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Butler AE, Janson J, Bonner-Weir S, Ritzel R, Rizza RA, Butler PC. Beta-cell deficit and increased beta-cell apoptosis in humans with type 2 diabetes. Diabetes. 2003 Jan;52(1):102-10. — View Citation
Meier JJ, Bhushan A, Butler AE, Rizza RA, Butler PC. Sustained beta cell apoptosis in patients with long-standing type 1 diabetes: indirect evidence for islet regeneration? Diabetologia. 2005 Nov;48(11):2221-8. Epub 2005 Oct 5. — View Citation
Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999 Jun 2;281(21):2005-12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome of the study is the change in total body insulin sensitivity due to RYGBP alone using the euglycemic hyperinsulinemic clamp technique. | Insulin sensitivity will be determined using the gold standard euglycemic hyperinsulinemic clamp method, which directly measures total body insulin sensitivity as the glucose disposal rate, M, during steady state conditions of euglycemia and hyperinsulinemia. A two- stage clamp will be performed, using first a low-dose insulin infusion (to determine hepatic insulin sensitivity), followed by a high-dose insulin infusion (to determine muscle insulin sensitivity). | 2 years | |
Secondary | The secondary outcomes are changes in insulin sensitivity, insulin secretion, and gut hormones due to caloric restriction alone, caloric restriction plus RYGBP, and RYGBP alone. | In addition to assessing total body insulin sensitivity, we will evaluate hepatic insulin sensitivity, insulin secretion and gut hormones for threeconditions:1. Diet alone (Before vs. after 6 day caloric restriction in the non-surgical group)2. Diet plus bariatric surgery (Before vs. after 6 day caloric restriction and surgery in the RYGBP group)3. Bariatric surgery alone (After 6 day caloric restriction in RYGBP group vs. non-surgical group) | 2 years |
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