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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus, Obesity

Intervention / Treatment
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* Procedure: Laparoscopic Gastric Bypass


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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