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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity
• Interventions: Procedure: Laparoscopic Gastric Bypass

• Registration Number: NCT02729246
• Lead Sponsor: Uppsala University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-06
• Primary Completion: 2019-12-30
• Study Completion: 2020-02-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery Group	Laparoscopic Gastric Bypass	The patients in this group will undergo Laparoscopic Gastric Bypass surgery

Primary Outcome Measures

Name	Time	Method
Change from Baseline of Glucose Turnover	1 month after surgery
Change from Baseline of beta cell function	1 month after surgery
Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance	1 month after surgery

Secondary Outcome Measures

Name	Time	Method
Change from Baseline of beta cell function	24 months after surgery
Change from Baseline of Glucose Turnover	24 months after surgery
Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance	24 months after surgery

Trial Locations

Locations (1)

Uppsala University, Department of Medical Sciences, Clinical diabetology and metabolism; 🇸🇪 Uppsala, Sweden