Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/03/2013
Date assigned
03/05/2013
Last edited
22/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
marubioh@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miguel A. Rubio

ORCID ID

Contact details

Department of Endocrinology and Nutrition
Hospital Clinico San Carlos
Martin Lagos s/n
Madrid
28040
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov 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.

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Type 2 diabetes

Intervention

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

Other

Phase

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

02/01/2013

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

02/01/2013

Recruitment end date

31/08/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Department of Endocrinology and Nutrition
Madrid
28040
Spain

Sponsor information

Organisation

Fundación Mutua Madrileña (Spain)

Sponsor details

Fortuny 18
Madrid
28010
Spain

Sponsor type

Government

Website

http://www.fundacionmutua.es

Funders

Funder type

Research organisation

Funder name

Fundación Mutua Madrileña de Investigación Biomédica (Spain) AP 89592011

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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