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

NCT ID: NCT01984762

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2025-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Type 2 Diabetes Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RYGBP

Roux-en-Y gastric bypass

Group Type ACTIVE_COMPARATOR

Roux-en-Y gastric bypass

Intervention Type PROCEDURE

RYGBP=Roux-en-Y gastric bypass

SG

sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

sleeve gastrectomy

Intervention Type PROCEDURE

SG = sleeve gastrectomy

Interventions

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Roux-en-Y gastric bypass

RYGBP=Roux-en-Y gastric bypass

Intervention Type PROCEDURE

sleeve gastrectomy

SG = sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Fändriks, MD, PhD, Professor

Role: STUDY_CHAIR

Göteborg University

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Ville R Wallenius, MD, PhD, Assoc Prof

Role: CONTACT

+46313428206

Almantas Maleckas

Role: CONTACT

+37068531143

Facility Contacts

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Ville R Wallenius, MD, PhD, Assoc Prof

Role: primary

+46313428206

Other Identifiers

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684-11

Identifier Type: -

Identifier Source: org_study_id

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