Skip to main content
OpenTrials
Completed

NCT Number: NCT02729246

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic gastric bypass

Procedure

Primary outcomes

  1. Change from Baseline of Glucose Turnover

    Time frame: 1 month after surgery

  2. Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance

    Time frame: 1 month after surgery

  3. Change from Baseline of beta cell function

    Time frame: 1 month after surgery

Secondary outcomes

  1. Change from Baseline of Glucose Turnover

    Time frame: 6 months after surgery

  2. Change from Baseline of Glucose Turnover

    Time frame: 24 months after surgery

  3. Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance

    Time frame: 6 months after surgery

  4. Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance

    Time frame: 24 months after surgery

  5. Change from Baseline of beta cell function

    Time frame: 6 months after surgery

  6. Change from Baseline of beta cell function

    Time frame: 24 months after surgery

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Acronym: Bariglykos

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Apr 6, 2016
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.