A Longitudinal Study on Short-term Effects of Gastric Bypass on Glucose Homeostasis in Obesity

NCT01063127 | Completed

• 1 other identifier: 749/09
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to quantify the relative contribution of improved insulin sensitivity and improved insulin secretion to the glycaemic effect of bariatric surgery.

Conditions

Morbid Obesity

Keywords

Morbid obesity; Insulin resistance; Euglycemic clamp

Outcome Measures

Primary Outcomes (1)

• Insulin sensibility pre and post bariatric surgery with euglycaemic hyperinsulinemic clamp (EHC)

  12 and 11 weeks before surgery and 1 week after surgery

Study Arms (2)

1

group A: 10 morbidly obese subjects who will undergo gastric banding will be studied basally, 1 week after low-calorie diet and 1 week after operation.

2

group B: 10 morbidly obese subjects who will undergo gastric bypass will be studied basally, 1 week after low-calorie diet and 1 week after operation.

Other: Study on insulin sensitivity after diet or bariatric surgery; Other: gastric bypass

Interventions

Study on insulin sensitivity after diet or bariatric surgery OTHER

Group A: 1 week of low calorie diet before gastric banding a new study 1 week after gastric banding Group B: 1 week of low calorie diet before gastric bypass a new study 1 week after gastric bypass

2

gastric bypass OTHER

Group B: 1 week of low calorie diet before gastric bypass a new study 1 week after gastric bypass

2

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Twenty morbidly obese subjects scheduled for RYGB or LAGB for will be included in the study.

You may qualify if:

• Morbidly obese subjects of both sexes with a BMI \>40 kg/m2 who, for their obesity disease, are eligible for bariatric surgery and have accepted to undergo RYGB or LAGB
• Confirmed insulin resistance as assessed by Matsuda index
• Age 25-55 years
• Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
• Stable medication
• Provision of informed consent, statistical analysis, and publications of obtained results

You may not qualify if:

• Patients not eligible for laparoscopic RYGB or LAGB
• Incapacity to give a valid informed consent or unwilling to give the consent
• Pregnancy or lactating
• Patients eligible for RYGB/LAGB, but with:
• Type 2-diabetes mellitus
• Significant illness within the two weeks preceding surgery, as judged by the physician.
• Obvious infection (bacteria, virus etc)
• Major cardiovascular disease

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Department of Internal Medicine, Catholic University

Rome, 00168, Italy

Location

Related Publications (6)

• Guidone C, Manco M, Valera-Mora E, Iaconelli A, Gniuli D, Mari A, Nanni G, Castagneto M, Calvani M, Mingrone G. Mechanisms of recovery from type 2 diabetes after malabsorptive bariatric surgery. Diabetes. 2006 Jul;55(7):2025-31. doi: 10.2337/db06-0068.

  PMID: 16804072 BACKGROUND

• Salinari S, Bertuzzi A, Iaconelli A, Manco M, Mingrone G. Twenty-four hour insulin secretion and beta cell NEFA oxidation in type 2 diabetic, morbidly obese patients before and after bariatric surgery. Diabetologia. 2008 Jul;51(7):1276-84. doi: 10.1007/s00125-008-1007-y. Epub 2008 May 6.

  PMID: 18458872 BACKGROUND

• Mingrone G. Role of the incretin system in the remission of type 2 diabetes following bariatric surgery. Nutr Metab Cardiovasc Dis. 2008 Oct;18(8):574-9. doi: 10.1016/j.numecd.2008.07.004.

  PMID: 18790374 BACKGROUND

• Ferrannini E, Mingrone G. Impact of different bariatric surgical procedures on insulin action and beta-cell function in type 2 diabetes. Diabetes Care. 2009 Mar;32(3):514-20. doi: 10.2337/dc08-1762. No abstract available.

  PMID: 19246589 BACKGROUND

• Mingrone G, Castagneto M. Bariatric surgery: unstressing or boosting the beta-cell? Diabetes Obes Metab. 2009 Nov;11 Suppl 4:130-42. doi: 10.1111/j.1463-1326.2009.01120.x.

  PMID: 19817795 BACKGROUND

• Gastaldelli A, Iaconelli A, Gaggini M, Magnone MC, Veneziani A, Rubino F, Mingrone G. Short-term Effects of Laparoscopic Adjustable Gastric Banding Versus Roux-en-Y Gastric Bypass. Diabetes Care. 2016 Nov;39(11):1925-1931. doi: 10.2337/dc15-2823. Epub 2016 Aug 29.

  PMID: 27573937 DERIVED

Biospecimen

Retention: NONE RETAINED

Blood sampling

MeSH Terms

Conditions

Obesity, Morbid; Insulin Resistance

Interventions

Bariatric Surgery; Gastric Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Gastroenterostomy; Anastomosis, Surgical; Digestive System Surgical Procedures

Study Officials

• Geltrude Mingrone, MD, PhD

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2012
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

IT (1)