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

Obesity Clinical Trial

— Bariglykos  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729246
• Other study ID #: Dnr 2014/255
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: February 10, 2020

Study information

• Verified date: March 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 10, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• Laparoscopic Gastric Bypass

Locations

Country	Name	City	State
Sweden	Uppsala University, Department of Medical Sciences, Clinical diabetology and metabolism	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of Glucose Turnover		1 month after surgery
Primary	Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance		1 month after surgery
Primary	Change from Baseline of beta cell function		1 month after surgery
Secondary	Change from Baseline of Glucose Turnover		6 months after surgery
Secondary	Change from Baseline of Glucose Turnover		24 months after surgery
Secondary	Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance		6 months after surgery
Secondary	Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance		24 months after surgery
Secondary	Change from Baseline of beta cell function		6 months after surgery
Secondary	Change from Baseline of beta cell function		24 months after surgery