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NCT Number: NCT06600555

Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes

Surgery is one of the management options for type 2 diabetes in patients with moderate obesity. This is a recent option because it has been part of the recommendations since October 2022.

The possible surgical techniques are the same as those for bariatric surgery:

* Sleeve, * Bypass, * Gastric band, but the main goal is not weight loss, it is remission of type 2 diabetes. It is called metabolic surgery.

The ring technique (gastroplasty) is practiced less and less in France because it is less effective in weight loss and is responsible for major discomfort.

Currently, metabolic surgery is one of the recommendations but no study has compared the effectiveness of the techniques with each other. One or other of the techniques can be chosen according to the preferences of the surgeon, the patient, the center, etc. but this choice is not made objectively, in the absence of comparative data.

This study would like to follow up on patients for whom metabolic surgery has been proposed by the doctor,.

If the surgery is accepted, this study would like to improve knowledge of the effectiveness of the different techniques, and thus demonstrate which metabolic surgery technique is preferred in terms of effectiveness and safety.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medipole Lyon Villeurbanne

Villeurbanne, 69100, France

Location status: Recruiting

Location contact

laetitia paradisi

CONTACT

0033481655296

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patient and ≤ 65 years old
  • T2D patient, with individualized glycemic objectives not achieved, despite medical care, in particular diabetological and nutritional, also including adapted physical activity, well conducted according to current good practice recommendations, for at least twelve months
  • BMI between 30 and 34.9 kg/m²
  • patient well informed beforehand about metabolic surgery and the study
  • multidisciplinary evaluation (including a diabetologist) and decision on medical treatment by CM (date prior to inclusion)
  • medical assessment of an acceptable surgical risk
  • patient affiliated to or beneficiary of a social security system
  • patient having freely signed the written informed consent

Exclusion criteria

  • severe cognitive or mental disorders
  • severe and unstabilized eating behavior disorders
  • dependence on alcohol and licit and illicit psychoactive substances
  • illnesses endangering life in the short and medium term
  • contraindications to general anesthesia
  • absence of identified prior medical care and foreseeable inability of the patient to participate in lifelong medical monitoring
  • history of bariatric surgery
  • pregnant or breastfeeding woman, or having a very long-term pregnancy plan short term (< 2 years)
  • adult patient under guardianship or curatorship
  • patient deprived of liberty or under judicial decision

Treatment and study plan

metabolic surgery with SLEEVE technique

Procedure

metabolic surgery with SLEEVE technique

metabolic surgery with BY-PASS technique

Procedure

metabolic surgery with BY-PASS technique

Primary outcomes

  1. T2DM remission rate

    Time frame: 1 year after surgery

    HbA1c lower than 6.5% in the absence of antidiabetic treatment, partial, complete, prolonged remission or no remission between the 2 surgical techniques

Study contacts

Contact information is provided by the study sponsor or research team.

laetitia paradisi, Dr

CONTACT

[email protected]

0033481655296

Sponsors and collaborators

Lead sponsor

Médipôle Lyon-Villeurbanne

Other

Registry information

Official study title

CHANGE Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes

Acronym: CHANGE

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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