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Bariatric Surgeries and Glucose Homeostasis During a Mixed Meal Test

NCT01767441 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2020-02-24

No results posted yet for this study

Summary

Bariatric surgery can lead to improvement or even resolution of type 2 diabetes Mellitus (T2DM) with the spectrum of responses depending also on operation procedures. However, many mechanisms of metabolic action of different surgical techniques still are unclear.

The aim of this study is to provide a better understanding of the effects of three types of bariatric surgery (lap banding, gastric bypass and sleeve gastrectomy) on beta-cell function and incretin secretion. A mixed meal tolerance (MMT) test will be performed before and 1 and 12 months after surgery to assess beta cell adequacy and glucagon-like-peptide-1 (GLP1)/glucose-dependent insulinotropic polypeptide (GIP) bioavailability.

Conditions

Interventions

PROCEDURE

Roux-en-Y-gastric bypass

Gastric bypass consisted of creation of a 15-20 ml gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb

PROCEDURE

laparoscopic adjustable gastric banding

Gastric banding functions by limiting food intake after the placement of an inflatable tube around the stomach just below the gastroesophageal junction, which allows for adjustment of the size of the outlet via the addition or removal of saline through a subcutaneous port.

PROCEDURE

laparoscopic sleeve gastrectomy

Sleeve gastrectomy involved a gastric reduction of 75 to 80% by resecting the stomach alongside a 30-French endoscope beginning 3 cm from pylorus and ending at the angle of His

OTHER

diet treatment

Hypocaloric diet providing a 1000 Kcal/d deficit from total energy expenditure assessed by indirect calorimetry and physical activity determination

Sponsors & Collaborators

  • Universita di Verona

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Principal Investigators

  • Maria Grazia Zenti, MD · Division of Endocrinology and Metabolic Diseases, AOUI Verona, Italy

  • Enzo Bonora, Professor · Division of Endocrinology and Metabolic Diseases, University Hospital of Verona

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01767441 on ClinicalTrials.gov