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

Purpose

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.

Condition	Intervention
Morbid Obesity	Other: Study on insulin sensitivity after diet or bariatric surgery Other: gastric bypass

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	A Longitudinal, Open-label Study on the Short-term Effects of Roux-en-Y Gastric Bypass Surgery vs. Gastric Banding on Glucose Homeostasis in Obese Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity Weight Loss Surgery

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

Insulin sensibility pre and post bariatric surgery with euglycaemic hyperinsulinemic clamp (EHC) [ Time Frame: 12 and 11 weeks before surgery and 1 week after surgery ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Blood sampling

Enrollment:	23
Study Start Date:	February 2010
Study Completion Date:	July 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 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 Other: gastric bypass Group B: 1 week of low calorie diet before gastric bypass a new study 1 week after gastric bypass

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Eligibility

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063127

Locations

Italy
Department of Internal Medicine, Catholic University
Rome, Italy, 00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators

Principal Investigator:

Geltrude Mingrone, MD, PhD

Catholic University of Sacred Heart

More Information

Additional Information:

Catholic University, Faculty of Medicine This link exits the ClinicalTrials.gov site

Publications:

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.

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. Epub 2008 May 6.

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.

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. Review. No abstract available.

Mingrone G, Castagneto M. Bariatric surgery: unstressing or boosting the beta-cell? Diabetes Obes Metab. 2009 Nov;11 Suppl 4:130-42.

Responsible Party:	Geltrude Mingrone, professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT01063127 History of Changes
Other Study ID Numbers:	749/09
Study First Received:	January 26, 2010
Last Updated:	February 14, 2013
Health Authority:	Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:

Morbid obesity
Insulin resistance
Euglycemic clamp

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight

Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013