Effects of Bariatric Surgery on Insulin

NCT00535600 | Completed

• 2 other identifiers: 99990722607-DK-N226
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Obesity; Bariatric Surgery; Gastric Bypass; Weight Loss; Hyperglycemia

Keywords

Bariatric Surgery; Insulin Action; Insulin Secretion; Insulin Resistance; Gut Hormones; Obesity

Eligibility Criteria

• Age: 18 Years - 96 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must initially qualify for bariatric surgery according to current NIH guidelines, which require the presence of either morbid obesity alone (BMI greater than 40 kg/m(2)) or a BMI greater than 35 kg/m(2) along with at least 2 other co-morbidities.
• Patients with conditions such as sleep apnea, mild steatohepatitis, GERD, asthma (not requiring oral steroids) and osteoarthritis can be considered for participation.
• Subject with undiagnosed diabetes (2-h glucose greater than 200 mg/dl during initial screening OGTT) will be included in the IGR group ONLY IF BOTH fasting plasma glucose is less than 126 mg/dl and HbA1c is less than 7 percent, suggesting early T2DM.
• Subjects must be at least 18 years of age and less than 150 kg body weight.
• Males and females of all ethnic minorities will be included.

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)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (3)

• Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.

  PMID: 15616203 BACKGROUND

• Pontiroli AE, Folli F, Paganelli M, Micheletto G, Pizzocri P, Vedani P, Luisi F, Perego L, Morabito A, Bressani Doldi S. Laparoscopic gastric banding prevents type 2 diabetes and arterial hypertension and induces their remission in morbid obesity: a 4-year case-controlled study. Diabetes Care. 2005 Nov;28(11):2703-9. doi: 10.2337/diacare.28.11.2703.

  PMID: 16249543 BACKGROUND

• Ferchak CV, Meneghini LF. Obesity, bariatric surgery and type 2 diabetes--a systematic review. Diabetes Metab Res Rev. 2004 Nov-Dec;20(6):438-45. doi: 10.1002/dmrr.507.

  PMID: 15386803 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss; Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism

Study Officials

• Joy C Bunt, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 26, 2007
• Study Start: September 21, 2007
• Study Completion: March 19, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-03-19

Locations

US (1)