Diabetes Remission and Hypoabsorptive Bariatric Surgery (DIABAR-3)

September 12, 2023 updated by: Nuria Vilarrasa, Hospital Universitari de Bellvitge

Prognostic Factors and Predictors of Diabetes Remission in Hypoabsorptive Bariatric Surgery Techniques. Randomized Comparative Study Between Duodenal Switch, Single-Anastomosis Duodenal Switch (SADI-S) and Mini-Gastric Bypass

Bariatric surgery is the most effective treatment to achieve type 2 Diabetes Mellitus (DM) remission in patients with severe obesity. However, there is little evidence of the effectiveness and pathophysiological mechanisms involved in metabolic improvement after hypoabsortive tecniques such as duodenal switch (DS), single anastomosis duodenal switch (SADI-S) or minigastric bypass (MGB). We have designed a randomized study to compare type 2 diabetes remission after the 3 bariatric procedures in patients with severe obesity (BMI > 45kg/m2) and to study the implication of gastrointestinal hormones, bile acids and gut microbiota in metabolic improvement in each procedure.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Patients fulfilling inclusion criteria will be randomly assigned 1:1:1 to undergo DS, SADI-S or MGB. Allocation of patients will be assigned by simple randomization with stratification according to baseline levels of HbA1c (greater or lower/ equal to 7 %).

Protocol 0. Screening visit: All participants will be required to sign the informed consent, according to the regulations of the Committee of the center. Clinical, analytical, and general physical examination data will be collected and it will be checked the fulfillment of inclusion criteria.

  1. Visit 1 (1 week after screening visit): Anthropometrical data will be collected, and general biochemical analytics including HbA1c, lipid profile and nutritional parameters and vitamins will be performed. Also a standard meal test (SMT) will be done with determination of GLP-1, PYY, GIP , and ghrelin, insulin, glucose and succinate concentrations before and during the SMT. A complete body composition study including DEXA, BIA and cardiac resonance to determine epicardia fat will be performed. Feces samples will be collected to determine gut microbiota. Quality of live questionnaire will be provided.
  2. Visit2 (1 month after surgery): Glycaemia diaries will be checked. Anthropometrical, general biochemical analysis with determination of HbA1c, lipid profile and nutritional parameters and vitamins will be done. SMT will be performed with determination of GLP-1, PYY, GIP, ghrelin, insulin, glucose. A determination of bile acids will be done before starting the meal test. feces samples will be collected to determine gut microbiota.
  3. Visit 3 (3 months after surgery): Glycaemia diaries will be checked. Anthropometrical, general biochemical analysis with determination of HbA1c, lipid profile and nutritional parameters and vitamins will be done.
  4. Visit 4 (12 months after surgery): The same determinations of visit 1 will be performed 12 months after surgery.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI>45 kg/m2
  • T2D on treatment with hypoglycemic agents alone, insulin or both.

Exclusion Criteria:

  • Type 1 diabetes
  • Positivity for GAD auto-antibodies
  • Secondary forms of diabetes
  • Acute metabolic complications in the last 6 months
  • Severe liver disease
  • Renal dysfunction
  • Patients under anticoagulant treatment
  • Previous bariatric surgery
  • Congenital or acquired abnormalities of the digestive tract
  • Pregnancy
  • Nursing or desired pregnancy in the 12 months following inclusion
  • Corticoid use by oral or intravenous route for more than 14 consecutive days in the last three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Duodenal switch
The restrictive portion of the surgery involves removing approximately 70% of the stomach (along the greater curvature) and most of the duodenum. The malabsorptive portion of the surgery reroutes a lengthy portion of the small intestine, creating two separate pathways and one common channel.The common channel is 200 cm and 100m the alimentary limb.
Procedure: Duodenal Switch
Classic Duodenal Switch
Active Comparator: SADI-S
Creation of a sleeve gastrectomy (SG) and a duodenal-ileal anastomosis with preservation of the pylorus, jejunal exclusion and a total common-alimentary limb, originally measuring 200 cm and later standardized to 300 cm to reduce the risk of nutritional deficiencies.
Procedure: SADI-S
SADI-S with a 300cm common channel
Other Names:
  • Single- Anastomosis Duodenal Switch
Active Comparator: Minigastric bypass
Creation of a gastric pouch similar to Sleeve gastrectomy and the small bowel is run to 200 cm distal to Treitz' ligament and then anastomosed antecolic end-to-side to the gastric pouch.
Procedure: Minigastric Bypass
Classic minigastric bypass
Other Names:
  • Single anastomosis or Omega loop gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type 2 Diabetes (T2D) remission.
Time Frame: 12 months
Number of participants achieving T2D remission (HbA1c <6.5% without anti-diabetic treatment) in each arm group one year after surgery.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 12 months
Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups
12 months
Entero-endocrine hormone GLP-1
Time Frame: 12 months
Changes in plasma concentrations of gut hormone GLP-1 from baseline to 12 months after surgery in the three arm groups
12 months
Entero-endocrine hormone PYY
Time Frame: 12 months
Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups
12 months
Entero-endocrine hormone GIP
Time Frame: 12 months
Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups
12 months
Entero-endocrine hormone Ghrelin
Time Frame: 12 months
Changes in plasma concentrations of gut hormone Ghrelin from baseline to 12 months after surgery in the three arm groups
12 months
Bile salts
Time Frame: 12 months
Changes in plasma concentrations of primary and secondary bile salts from baseline to 12 months after surgery in the three arm groups
12 months
Intestinal microbiome
Time Frame: 12 months
Changes in the ratio of Firmicutes and bacteroidetes species from baseline to 12 months after surgery in the three arm groups
12 months
Epicardial fat
Time Frame: 12 months
Changes in epicardial fat from baseline to 12 months after surgery measured in mm2 in the three arm groups
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Nuria Vilarrasa García, PhD, MD, Medical doctor at Hospital Universitari de Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

June 11, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR015/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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