Diabetes Mellitus, Type 2CHANGENCT06600555
Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
A study testing metabolic surgery with SLEEVE technique and metabolic surgery with BY-PASS technique in people with Diabetes Mellitus, Type 2 and Obesity, run by Médipôle Lyon-Villeurbanne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- metabolic surgery with SLEEVE technique and metabolic surgery with BY-PASS technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2024to 1 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Medipole Lyon Villeurbanne
Villeurbanne, 69100
laetitia paradisi, 0033481655296
About this study
Official title: CHANGE 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:
Read more
- 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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- metabolic surgery with SLEEVE technique, metabolic surgery with BY-PASS technique
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolic surgery with SLEEVE techniqueProcedure or surgery
metabolic surgery with SLEEVE technique
metabolic surgery with BY-PASS techniqueProcedure or surgery
metabolic surgery with BY-PASS technique
| Study group | Role | What they receive |
|---|---|---|
| metabolic surgery with SLEEVE technique | Experimental | Not described Receives: Procedure: metabolic surgery with SLEEVE technique |
| metabolic surgery with BY-PASS technique | Experimental | Not described Receives: Procedure: metabolic surgery with BY-PASS technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2DM remission rate
HbA1c lower than 6.5% in the absence of antidiabetic treatment, partial, complete, prolonged remission or no remission between the 2 surgical techniques
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Jul 2024
- Primary completion1 Dec 2032 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Médipôle Lyon-Villeurbanne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600555
- Sponsor's protocol ID
- CHANGE metabolic surgery
- Acronym
- CHANGE
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHANGE Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06600555
- Acronym / sponsor ID
- CHANGE / CHANGE metabolic surgery
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Médipôle Lyon-VilleurbanneUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 1 Dec 2032 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metabolic surgery with SLEEVE technique | Experimental | Procedure: metabolic surgery with SLEEVE technique |
| metabolic surgery with BY-PASS technique | Experimental | Procedure: metabolic surgery with BY-PASS technique |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metabolic surgery with SLEEVE techniquemetabolic surgery with SLEEVE technique | Procedure or surgery | metabolic surgery with SLEEVE technique |
| metabolic surgery with BY-PASS techniquemetabolic surgery with BY-PASS technique | Procedure or surgery | metabolic surgery with BY-PASS technique |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metabolic surgery with SLEEVE technique and metabolic surgery with BY-PASS technique in people with Diabetes Mellitus, Type 2 and Obesity, run by Médipôle Lyon-Villeurbanne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact laetitia paradisi, Dr (0033481655296, l.paradisi-prieur@resamut.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2DM remission rate (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.