Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy

August 5, 2019 updated by: Lund University

Study of Incretins Response and Glycemic Control: Pre Diet, After Conventional Weight Loss and in the Early Postoperative Phase After Gastric Bypass in T2D-patients.

The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Sweden
- - Kalmar, Sweden, 39185
    - Kalmar County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

female obese (BMI>35)patients accepted for bariatric surgery (lap gastric bypass). 10 patients with type 2 diabetes(T2D) 6 10 matched controls without T2D.

Description

Inclusion Criteria:

clinical diagnosis of type 2 diabetes
obesity BMI >35

Exclusion Criteria:

prior bariatric surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in incretines in the bariatric patient Time Frame: 2 months prior to surgery - 6 weeks post surgery	standardized meals prior to pre op diet, day before surgery, first day after surgery and 6 weeks after surgery.	2 months prior to surgery - 6 weeks post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes control Time Frame: 6 weeks post surgery	resolution of t2D as early as first day after surgery	6 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Kalmar County Hospital

Investigators

Study Director: Nils Wierup, Lunds Universitet, Clinical researchcenter
Principal Investigator: Johan Berggren, MD, Lunds Universitet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified