Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms (Bariglykos)

March 30, 2020 updated by: Uppsala University
The main purpose of this project is to further explore the metabolic effects and the mechanisms underlying the improvement in glucose homeostasis following bariatric surgery. The project will involve both prevention and treatment of Type 2 Diabetes (T2D), and both pre-diabetic as well as diabetic subjects with obesity will be included. This part of the project focuses on patients with manifest T2D and they will be assigned to surgical and non-surgical intervention, respectively, in a strictly controlled and randomized manner.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

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
      • Uppsala, Sweden
        • Uppsala University, Department of Medical Sciences, Clinical diabetology and metabolism

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females aged 18-60 years
  • Type 2 Diabetes Mellitus with duration of no more than 10 years, treated with 0-3 oral anti-diabetic drugs or Glucagon-like peptide-1 (GLP-1) analog.

Exclusion Criteria:

  • Pregnant or planning to be pregnant during the study.
  • Known or suspected history of significant drug abuse.
  • History of alcohol abuse or excessive intake of alcohol as judged by investigator.
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator
  • Sleep apnea
  • Any previous serious cardiovascular event, stroke , acute myocardial infarction.
  • Diabetes complications : proliferative retinopathy, maculopathy, chronic renal failure stadium 3 with an Estimated Glomerular Filtration Rate (eGFR) <60, foot ulcers, symptomatic neuropathy
  • Medications within 3 months : Insulin, Thiazolidinediones
  • Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety
  • Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Other: Surgery Group
The patients in this group will undergo Laparoscopic Gastric Bypass surgery
Procedure: Laparoscopic Gastric Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline of Glucose Turnover
Time Frame: 1 month after surgery
1 month after surgery
Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
Time Frame: 1 month after surgery
1 month after surgery
Change from Baseline of beta cell function
Time Frame: 1 month after surgery
1 month after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline of Glucose Turnover
Time Frame: 6 months after surgery
6 months after surgery
Change from Baseline of Glucose Turnover
Time Frame: 24 months after surgery
24 months after surgery
Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
Time Frame: 6 months after surgery
6 months after surgery
Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
Time Frame: 24 months after surgery
24 months after surgery
Change from Baseline of beta cell function
Time Frame: 6 months after surgery
6 months after surgery
Change from Baseline of beta cell function
Time Frame: 24 months after surgery
24 months after surgery

Collaborators and Investigators

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

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Jan Eriksson, Professor, Department of Medical Sciences, Clinical diabetology and metabolism

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2014

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

February 10, 2020

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2014/255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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