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Enrolling by Invitation

NCT Number: NCT06043245

Diabetes Remission and Hypoabsorptive Bariatric Surgery

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

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.

  • 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.
  • 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.
  • 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.
  • Visit 4 (12 months after surgery): The same determinations of visit 1 will be performed 12 months after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duodenal Switch

Procedure

Classic Duodenal Switch

SADI-S

Procedure

SADI-S with a 300cm common channel

Other names: Single- Anastomosis Duodenal Switch

Minigastric Bypass

Procedure

Classic minigastric bypass

Other names: Single anastomosis or Omega loop gastric bypass

Primary outcomes

  1. 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.

Secondary outcomes

  1. Weight loss

    Time frame: 12 months

    Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: DIABAR-3

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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