Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/11/2015
Date assigned
25/01/2016
Last edited
25/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Once of the main reasons why people develop T2DM is because they are overweight or obese. Weight loss surgery, also called bariatric surgery, is a drastic measure used to help people who are dangerously overweight. There are a number of different types of bariatric surgery; however they all work by limiting the amount a person can eat or reducing the number of calories that are absorbed from food. Recent studies have shown that when a person undergoes bariatric surgery, the following weight loss can lead to an improvement in the diabetes symptoms. In many people, once they have lost the excess weight, their diabetes improves. The aim of this study is to compare the effects of three different types of weight loss surgery to find out if losing weight following surgery has an effect on diabetes.

Who can participate?
Obese adults between 18 and 60 years, who have type 2 diabetes mellitus (T2DM).

What does the study involve?
Participants are randomly allocated to one of three groups. Participants in the first group undergo the metabolic gastric bypass procedure. This is where the stomach is stapled, making it smaller and the small intestine is made shorter. Participants in the second group undergo a sleeve gastrectomy procedure. This is where part of the stomach is removed, making the overall size of the stomach smaller. Participants in the third group undergo a gastric plication procedure. This is where folds are “sewn” into the stomach, which limits the amount of food that can be eaten at one time. At the start of the study and then again 1, 3 and 12 months after surgery, the weight and body fat of participants in all groups is measured at clinic visits. Blood sugar and other markers of diabetes are also measured at these times, to find out if the surgery has had an influence on their diabetes.

What are the possible benefits and risks of participating?
Participants of the study will benefit from shorter waiting times until they are able to receive their bariatric surgery. They will also be closely followed-up by the research team which measures that any problems would be quickly spotted. Risks of participating include the general risks associated with major surgery. Participants who receive the gastric bypass may also have a greater risk of leaking, bleeding and nutritional deficiencies (not getting enough vitamins and minerals in the diet as they are unable to eat as much).

Where is the study run from?
Bellvitge's University Hospital (Spain)

When is the study starting and how long is it expected to run for?
May 2012 to February 2014

Who is funding the study?
Bellvitge Institute for Biomedical Research (Spain)

Who is the main contact?
Dr Tsung-Hui Hu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nuria Vilarrasa Garcia

ORCID ID

http://orcid.org/0000-0003-3188-1990

Contact details

Feixa llarga s/n
Hospitalet de Llobregat
Barcelona
08907
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI11/01960

Study information

Scientific title

Prognostic factors and pathophysiology of type 2 diabetes mellitus remission following bariatric surgery. gastric bypass, sleeve gastrectomy and greater curvature plication: A randomised controlled trial

Acronym

DIABETCIR

Study hypothesis

A higher increase in GLP-1 after metabolic gastric bypass compared to sleeve gastrectomy and greater curvature plication will be associated to a greater metabolic improvement in the short (1 month) and mid- term (12 months) after this surgery for the same amount of weight loss achieved. Patients with higher concentrations of GLP-1 receptors in adipose tissue will have a greater metabolic improvement after surgery.

Ethics approval

Bellvitge's Clinical Research and Ethics Committee from Barcelona, 26/01/2012, ref: PI11/01960

Study design

Single-centre non-blinded randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Morbid Obesity and Type 2 Diabetes Mellitus improvement after bariatric surgery

Intervention

Patients are randomly assigned (1:1:1) to three groups using envelope stratification according to the presence of an initial hba1c > or < 7%.

Group 1: Participants undergo a metabolic gastric bypass, a mixed bariatric technique (restrictive pouch and a biliopancreatic limb length of 200cm and alimentary limb of 100cm)
Group 2: Participants undergo a sleeve gastrectomy, a restrictive technique performed over a 36Fr bougie
Group 3: Participants undergo gastric plication, a restrictive technique without gastrectomy and no bowel derivation. It is a greater gastric curvature invagination with two running non absorbable suture, over a 36Fr bougie.

The same surgeon performs all the procedures by laparoscopy. Study participants attend visits at baseline and 1, 3 and 12 months after the three surgical techniques. Postoperative diet progression and medical follow-up is the same for all patients. At each visit, anthropometric and biochemical parameters including glucose, HbA1c, and lipid profile are determined. A study of body composition with DEXA is conducted at baseline and at 12 months after surgery. A standard meal test for determination of plasma GLP-1, glucagon, PYY, ghrelin, insulin and glucose is performed at baseline and at 1 and 12 months after surgery. During the intervention a sample of visceral and subcutaneous adipose tissue is collected.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. GLP-1, glucagon, PYY, Ghrelin, glucose and insulin changes measured using a standard meal test at baseline, 1, 3 and 12 months
2. Weight changes are measured using anthropometric techniques at baseline, 1, 3 and 12 months
3. Body fat changes are measured using Dual-energy X-ray absorptiometry (DEXA) at baseline and 12 months
4. Presence of GLP-1 receptors in adipose tissue is measured from a sample of visceral and subcutaneous adipose tissue at baseline

Secondary outcome measures

1. Rate of total, partial and non- T2DM remission is measured using Buse criteria at 12 months
2. Blood pressure changes are measured using a sphygmomanometer at baseline and 12 months
3. Plasma total cholesterol, HDL and triglycerides changes are measured from blood samples at baseline and 12 months
4. Quality of life is measured using the Moorehead-Ardelt II test at 12 months

Overall trial start date

10/05/2012

Overall trial end date

28/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 60 years
2. BMI of 35-42Kg/m2
3. Diagnosis of type 2 diabetes mellitus (T2DM)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

Participant exclusion criteria

1. Type 1 diabetes
2. Diabetes secondary to pancreatic injury or other disease (Cushing's syndrome or acromegaly)
3. Presence of GAD auto-antibodies
4. Acute metabolic complications (ketosis, ketoacidosis or hyperosmolar state over the last six months)
5. Serious infection that can affect blood glucose control during the 4 weeks prior inclusion
6. Cardiovascular events (heart failure, angina pectoris, myocardial infarction or stroke) within 6 months prior to inclusion
7. History of liver disease (chronic active hepatitis or cirrhosis) and/or abnormal liver function (ALT and/or AST 3 times above the upper normal value)
8. Altered renal function (creatinine >1.4 mg/dl in women and 1.5 mg/dl in men)
9. Patients with anticoagulant therapy
10. Congenital or acquired abnormalities of the digestive tract (atresia, stenosis)
11. Pregnancy, nursing or desired pregnancy in the 12 months following the inclusion
12. Recent history of neoplasm (<5 years) except basal cell skin cancer
13. Glucocorticoid use by oral or intravenous route for more than 14 consecutive days in the last three months prior to inclusion
14. Alcoholism, drug addiction or major psychiatric disorder
15. Patient refusal to participate in the study

Recruitment start date

10/05/2012

Recruitment end date

28/02/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Bellvitge's University Hospital
Feixa Llarga n/n
Hospitalet de Llobregat, Barcelona
08907
Spain

Sponsor information

Organisation

Bellvitge Institute for Biomedical Research (IDIBELL)

Sponsor details

Hospital Duran i Reynals (3th floor)
Gran Via de les Corts Catalanes
199-203
Barcelona
08907
Spain

Sponsor type

Hospital/treatment centre

Website

http://www.ub.edu/web/ub/en/recerca_innovacio/recerca_a_la_UB/instituts/institutsparticipats/idibell.html?

Funders

Funder type

University/education

Funder name

Bellvitge Institute for Biomedical Research (IDIBELL)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in peer reviewed scientific journals.

Intention to publish date

01/05/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes