Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus.

NCT01984762 | Recruiting

• 1 other identifier: 684-11
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a growing epidemic throughout the world and is followed by increasing incidence of type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major objective, although difficult to achieve with medical treatments. Many recent studies demonstrated that bariatric surgery has the potency to achieve marked and sustained weight loss, and is also associated with a significant improvement in control of type 2 diabetes. The principal aim of this study is to compare two types of bariatric procedures, the Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that these procedures have equal efficacy with regard to resolution of type 2 diabetes.

Conditions

Obesity; Type 2 Diabetes; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Rate of resolution of type 2 diabetes

  5 years

Secondary Outcomes (1)

• postoperative complications

  5 years

Other Outcomes (1)

• Glycemic control mechanisms

  5 years

Study Arms (2)

RYGBP

ACTIVE COMPARATOR

Roux-en-Y gastric bypass

Procedure: Roux-en-Y gastric bypass

SG

ACTIVE COMPARATOR

sleeve gastrectomy

Procedure: sleeve gastrectomy

Interventions

Roux-en-Y gastric bypass PROCEDURE

RYGBP=Roux-en-Y gastric bypass

RYGBP

sleeve gastrectomy PROCEDURE

SG = sleeve gastrectomy

SG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 2 diabetes mellitus
• BMI between 35 and 50kg/m2.
• Males and females
• Age between 18 and 60 years.

You may not qualify if:

• Severe ongoing psychiatric disorder, alcoholism and substance abuse.
• Redo operations after previous bariatric procedures.
• Type 1 diabetes or other non-type 2 forms of diabetes
• End stage renal disease, retinopathy, neuropathy

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, SE41345, Sweden

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Lars Fändriks, MD, PhD, Professor

  Göteborg University

  STUDY CHAIR

Central Study Contacts

Ville R Wallenius, MD, PhD, Assoc Prof

CONTACT

+46313428206; ville.wallenius@gastro.gu.se

Almantas Maleckas

CONTACT

+37068531143; almantas_maleckas@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 15, 2013
• Study Start: September 1, 2012
• Primary Completion: October 1, 2025
• Study Completion: October 10, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

SE (1)