Effects of Bariatric Surgery on Insulin

Completed

Conditions studied: Obesity, Bariatric Surgery, Gastric Bypass, Weight Loss, Hyperglycemia

In brief

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: * Blood and urine tests, including a pregnancy test for women. (4-day and 2-day admissions and years, 3, 4 and 5) * DEXA, an x-ray scan to determine body fat content. (4-day and 2-day admissions and years, 3, 4 and 5) * MRI scan to measure fat tissue in the abdomen. (4-day and 2-day admissions and years, 3, 4 and 5) * Intravenous (I.V.) glucose tolerance test for risk of obesity and diabetes. A sugar solution is given through a needle in a vein of one arm and blood samples are drawn through another needle in a vein in the other arm. (4-day admissions) * Meal test to measure blood sugar and insulin and gut hormone levels after a meal. After an I.V. line is placed in an arm vein, the subject eats breakfast over 20 minutes. Blood samples are collected halfway through the meal, at the end of the meal, and at 15, 30, 60, 90, 120 and 180 minutes after completing the meal. Subjects fill out questionnaires on feelings of hunger and fullness before, during and after the meal test. (4-day and 2-day admissions) * Glucose clamp test to measure the effect on the body of insulin given through a vein. An I.V line is placed in a vein in the arm and in a vein of the hand on the other side of the body. While insulin is infused through one I.V., blood sugar levels are checked every 5 minutes and a sugar solution is given into a vein as needed. A radioactive sugar is also infused very slowly over 4 hours to determine how much sugar the body produces by itself. (4-day admissions)

Key facts

Study ID: NCT00535600
Run by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
People needed: 28
Starts: 2007-09-21
Expected to finish: 2014-03-19
Last updated by the study team: 2019-12-17

Who can join

Age: 18 and older, up to 96. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

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:
Current smoking
Previously diagnosed diabetes
Other endocrine disorders, such as Cushing's disease, pituitary disorders, and thyroid disease
Significant hepatic or renal disease (ALT and AST greater than 3-fold above upper limit of normal range, cirrhosis, active hepatitis B or C, serum creatinine greater than 1.5 mg/dl or presence of protein in urine dipstick)
Active tuberculosis (self-report)
Major pulmonary disorders including physician diagnosed chronic obstructive pulmonary diseases other than obstructive sleep apnea
Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
Hypertension (according to the World Health Organization diagnostic criteria), treated or uncontrolled
Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active)
Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis
Psychiatric conditions or behavior or current alcohol or illicit drug use that would be incompatible with safe and successful participation in this study
Recent use (within 30 days) of anorexiant medications, antibiotics, contraceptives or fertility drugs or recent use (within 5 days) of anti inflammatory agents
Pregnancy or breastfeeding (to avoid radiation exposure to fetus or nursing infant)

Where it is running

NIDDK, Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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