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NCT Number: NCT01984762

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

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.

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Key information

Conditions

Obesity Bariatric Surgery Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, SE41345, Sweden

Location status: Recruiting

Location contact

Ville R Wallenius, MD, PhD, Assoc Prof

CONTACT

[email protected]

+46313428206

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Roux-en-Y gastric bypass

Procedure

RYGBP=Roux-en-Y gastric bypass

Sleeve gastrectomy

Procedure

SG = sleeve gastrectomy

Primary outcomes

  1. Rate of resolution of type 2 diabetes

    Time frame: 5 years

Secondary outcomes

  1. postoperative complications

    Time frame: 5 years

    Post-operative (within 30 days) bleeding, staple line/anastomotic leakage, infection, deep venous thrombosis, pulmonary embolism, resubmission. Questionnaires for health related quality of life (SF-36), gastroesophageal reflux symptoms (Carlsson-Dent), gastrointestinal symptom rating scale (GSRS) and food intake (SOS food questionnaire), recorded pre-operatively and at 6 weeks to 60 months post-operatively.

Other outcomes

  1. Glycemic control mechanisms

    Time frame: 5 years

    Oral glucose tolerance tests comparing blood glucose, insulin and and other gastrointestinal hormone levels within and between the intervention groups pre- and post-operatively.

Study contacts

Contact information is provided by the study sponsor or research team.

Almantas Maleckas

CONTACT

[email protected]

+37068531143

Ville R Wallenius, MD, PhD, Assoc Prof

CONTACT

[email protected]

+46313428206

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Acronym: CONTROL

Important dates

Study start
2012
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2013
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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