Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Bariatric surgery (weight loss surgery) improves and resolves Type 2 Diabetes (T2D) by several weight-loss-independent mechanisms. Secretion of gastrointestinal hormones may contribute to this. The objective of this study is to analyze the changes in gastrointestinal hormones of less obese patients [Body mass Index (BMI) < 40 kg/m2], after two different surgery techniques. It also analyzes genetic variations (genetic polymorphisms) involved.

Who can participate?
Men and women, aged 30-65, with T2D and BMI 30-40 kg/m2.

What does the study involve?
Patients will be randomly allocated to one of two groups to undergo either gastric bypass (RYGB) or sleeve gastrectomy (SG). Both are routinely performed as metabolic surgery techniques. Blood samples will be collected before surgery, at 6 weeks, and at 12-months. Each time, measurements will take place every 30 minutes, for 3 hours, after a fixed liquid meal. Several hormone tests will be performed.

What are the possible benefits and risks to participants?
Benefits are improvement of obesity and associated problems. Risks are those of a surgical intervention.

Where is the study run from?
In two renowned bariatric surgery reference centres: Hospital Clinico San Carlos, Madrid, Spain, and Hospital Oswaldo Cruz, Sao Paulo, Brazil

When is the study starting and how long is it expected to run for?
Recruitment started on January 2013 and will continue for a period of 20 months. Participants will take part in the study for one year. However, they will be followed up for longer period.

Who is funding the study?
Funding has been provided by the Fundación Mutua Madrileña de Investigación Biomédica.

Who is the main contact?
Dr. Miguel Ángel Rubio

Trial website

Contact information



Primary contact

Dr Miguel A. Rubio


Contact details

Department of Endocrinology and Nutrition
Hospital Clinico San Carlos
Martin Lagos s/n

Additional identifiers

EudraCT number number

Protocol/serial number

Fundación Mutua Madrileña de Investigación Biomédica AP 89592011

Study information

Scientific title

Role of gastrointestinal hormones and genes associated to type 2 diabetes remission in non-morbid obesity after bariatric surgery. A multicentric, randomized trial using different bariatric techniques.


Study hypothesis

T2D long-term remission differs between bariatric procedures, beyond the effect of weight loss and the GLP-1 response. In restrictive techniques, weight loss is still the main mechanism involved, but in bypassed procedures, liberation of other related hormones may contribute to the action of GLP-1. In RYGB, both mechanisms may coexist. Evaluation of T2D patients with only grade 1 obesity should minimize the influence of weight on the evaluation of these hormonal changes.

Ethics approval

The ethics committee of the Hospital Clinico San Carlos approved the study on 21st September 2011 (reference number CI-11/080-E)

Study design

Three-year open randomized prospective trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Type 2 diabetes


Eligible patients with T2D and grade 1 obesity will be randomized to undergo either gastric bypass (RYGB) (performed laparoscopically, with a 150 cm-alimentary limb and a 100-cm-biliopancreatic limb) or sleeve gastrectomy (SG) (also performed laparoscopically, following standardized technique and a 14-Fr bougie)

Intervention type



Not Applicable

Drug names

Primary outcome measures

Remission of type 2 diabetes after metabolic surgery, defined as two categories: complete remission (fasting glucose < 100 mg/dl, normal HbA1c values) and partial remission (fasting glucose 100-125 mg/dl, HbA1c < 6.5%), in both cases in the absence of active pharmacologic treatment, at each time of follow-up (T1 and T2)

Secondary outcome measures

1. Changes in gastrointestinal hormones (ghrelin, insulin, glucagon, GIP, GLP-1, PYY3-36, oxyntomodulin, adiponectin, leptin and GLP-2) using values of area under the curve (AUC), for each bariatric procedure and comparison with a matched control group
2. Analysis of polymorphisms involved in type 2 diabetes and incretin metabolism

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Men and women
2. Ages 35-60
3. Type 2 diabetes diagnosed 1-10 years prior to recruitment
4. Body mass index (BMI) 30-40 kg/m2
5. C-peptide level > 1 ng/dL
6. Signed written informed consent

Participant type


Age group




Target number of participants

It is estimated that a minimum of 30 patients for each type of surgery which means a total of 60 participants, over a 20-month period

Participant exclusion criteria

1. HbA1c levels > 6.5% or > 10% at the time of recruitment
2. Creatinine levels > 1.5 mg/dL
3. Ongoing pregnancy, either at the time of recruitment or follow-up
4. Renal failure (ClCr < 50 mL/min)
5. Liver disease
6. Psychiatric disorders

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Department of Endocrinology and Nutrition

Sponsor information


Fundación Mutua Madrileña (Spain)

Sponsor details

Fortuny 18

Sponsor type




Funder type

Research organisation

Funder name

Fundación Mutua Madrileña de Investigación Biomédica (Spain) AP 89592011

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes