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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01063127
First received: January 26, 2010
Last updated: February 14, 2013
Last verified: February 2013
  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:


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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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 July 24, 2014