ObesityCONTROLNCT01984762
Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus.
A study testing Roux-en-Y gastric bypass and sleeve gastrectomy in people with Obesity and Type 2 Diabetes, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Type 2 Diabetes, Bariatric Surgery
- What is being tested?
- Roux-en-Y gastric bypass and sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes mellitus
- BMI between 35 and 50kg/m2.
- Males and females
- Age between 18 and 60 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, SE41345
Ville R Wallenius, MD, PhD, Assoc Prof, +46313428206, ville.wallenius@gastro.gu.se
About this study
Official title: Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. Randomised Controlled Trial
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
- Being tested
- Roux-en-Y gastric bypass, sleeve gastrectomy
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypassProcedure or surgery
RYGBP=Roux-en-Y gastric bypass
sleeve gastrectomyProcedure or surgery
SG = sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| RYGBP | Active comparator | Roux-en-Y gastric bypass Receives: Procedure: Roux-en-Y gastric bypass |
| SG | Active comparator | sleeve gastrectomy Receives: Procedure: sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of resolution of type 2 diabetes
Measured: 5 years
Secondary outcomes (1)
postoperative complications
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startSep 2012
- Primary completion1 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Fändriks, MD, PhD, Professor, Study chair, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984762
- Sponsor's protocol ID
- 684-11
- Acronym
- CONTROL
- Status last verified
- Apr 2025
- First submitted
- 29 Oct 2013
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01984762
- Acronym / sponsor ID
- CONTROL / 684-11
- Conditions
- Obesity, Type 2 Diabetes, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGBP | Active comparator | Procedure: Roux-en-Y gastric bypassRoux-en-Y gastric bypass |
| SG | Active comparator | Procedure: sleeve gastrectomysleeve gastrectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus
- BMI between 35 and 50kg/m2.
- Males and females
- Age between 18 and 60 years.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypassRYGBP=Roux-en-Y gastric bypass | Procedure or surgery | RYGBP |
| sleeve gastrectomySG = sleeve gastrectomy | Procedure or surgery | SG |
Primary outcome
Rate of resolution of type 2 diabetes
Time frame: 5 years
1 secondary outcome
postoperative complications
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Fändriks, MD, PhD, Professor study chair
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y gastric bypass and sleeve gastrectomy in people with Obesity and Type 2 Diabetes, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ville R Wallenius, MD, PhD, Assoc Prof (+46313428206, ville.wallenius@gastro.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of resolution of type 2 diabetes (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.