Severe ObesitySLEEVEDIABNCT02076880
SLEEVEDIAB To Explore the Early and Late Metabolic Effects of Sleeve Gastrectomy in Obese Patients
A study testing Caloric restriction and No caloric restriction in people with Severe Obesity and Type 2 Diabetes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the gastric fundus. According to a recent randomized study, weight loss and resolution of diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but with a lower morbidity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Obesity, Type 2 Diabetes
- What is being tested?
- Caloric restriction and No caloric restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- written informed consent
- Age between 18-65 years (inclusive)
- Men or women receiving effective contraception, postmenopausal or sterile
- type 2 diabetes treated with no drugs or oral anti-diabetic agents metformin, sulfonylurea or glinides
- Body mass index 35 kg / m² or above
- eligible to bariatric surgery according to HAS criteria
Who cannot join
- Treatment of diabetes with GLP1 analogues, DPP-IV (dipeptidyl-peptidase IV) or insulin
- Treatment with drugs that modify glucose homeostasis: glucocorticoids, anorexigens, antihistaminics, psychotropic drugs especially serotonergic antidepressants (except for the occasional use of a hypnotic or anxiolytic), atropine, laxatives, thyroid hormones (with the exception of a substitution dose ensuring a stable euthyroid at baseline), beta blockers, diuretics
- Pregnancy, intention of being pregnant, breastfeeding.
- Inability to understand the nature and aims of the study or to communicate with the investigator- High probability of non
- compliance with the protocol
- Simultaneous participation in another trial
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- No affiliation to the French social security
- Loss of personal capacity resulting in state protection
- Deprivation of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
Florence GALTIER, MD contact
Eric RENARD, PU-PH contact
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier, 34295
GALTIER Florence, f-galtier@chu-montpellier.fr
GALTIER Florence, MD
About this study
Official title: Investigation of Endocrin-metabolic Modifications Related to Diabetes Improvement After Sleeve Gastrectomy in Severly Obese
Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the gastric fundus. According to a recent randomized study, weight loss and resolution of diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2 diabetic obese are available. An increase in post- absorptive levels of Glucagon-like Peptide 1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic subjects mostly. The important caloric restriction in the early postoperative period indeed improves hepatic insulin resistance, regardless of weight loss. Specific metabolic and hormonal effects of this surgical procedure cannot be excluded.The aim of our study is to explore the early and late metabolic effects of sleeve gastrectomy in severely obese patients with non-insulin-treated type 2 diabetes. We will also evaluate insulin sensitivity, insulin secretion and incretin effect. We will include 14 obese patients with type 2 diabetes, considered eligible to bariatric surgery according to HAS criteria, and whose diabetes treatment involves only metformin, sulfonylurea and glinides. They will be randomized to a 1-week caloric restriction period or no caloric restriction, immediately before surgery. Test meals with dosages of blood glucose, insulin, C-peptide, adiponectin, leptin, GLP-1, PYY and ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month and 12 month after surgery.
- Conditions
- Severe Obesity, Type 2 Diabetes
- Being tested
- Caloric restriction, No caloric restriction
- Keywords
- Type 2 diabetes, Obesity, Sleeve gastrectomy, Insulin, GLP-1
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Type 2, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restrictionOther
Caloric restriction of 1000 kcal per day compared to the usual food intake.
- usual breakfast of the patient (possibly limited in quantity)
- midday and evening meals from mixed and dehydrated meals, soups with protein and dairy desserts sweetened
No caloric restrictionOther
No change in eating habits to patients in this arm
| Study group | Role | What they receive |
|---|---|---|
| Arm with caloric restriction | Experimental | Patients in this arm will have, during 7 days before surgery, a caloric restriction of 1000 kcal per day compared to the usual food intake. They will be hospitalized during this period.
Intervention: caloric restriction Receives: Other: Caloric restriction |
| Arm without caloric restriction | Experimental | Patients in this arm will not have a caloric restriction before surgery.
Intervention: No caloric restriction Receives: Other: No caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of area under the curve of post prandial glycemia
Measured: Baseline to day 7 after surgery
Secondary outcomes (1)
Change in insulin sensitivity, Change in insulin secretion, Change in incretins
Measured: Blood samples at D-15, D-7 before surgery, D7, D80, D170, D350 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2016 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence GALTIER, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076880
- Sponsor's protocol ID
- 9016
- Other IDs
- 2012-A00962-41
- Acronym
- SLEEVEDIAB
- Status last verified
- Sep 2013
- First submitted
- 17 Dec 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Endocrin-metabolic Modifications Related to Diabetes Improvement After Sleeve Gastrectomy in Severly Obese
- ClinicalTrials.gov ID
- NCT02076880
- Acronym / sponsor ID
- SLEEVEDIAB / 9016
- Conditions
- Severe Obesity, Type 2 Diabetes
- Keywords
- Type 2 diabetes, Obesity, Sleeve gastrectomy, Insulin, GLP-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 4 Mar 2014 (estimated)
- 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.
Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the gastric fundus. According to a recent randomized study, weight loss and resolution of diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2 diabetic obese are available. An increase in post- absorptive levels of Glucagon-like Peptide 1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic subjects mostly. The important caloric restriction in the early postoperative period indeed improves hepatic insulin resistance, regardless of weight loss. Specific metabolic and hormonal effects of this surgical procedure cannot be excluded.The aim of our study is to explore the early and late metabolic effects of sleeve gastrectomy in severely obese patients with non-insulin-treated type 2 diabetes. We will also evaluate insulin sensitivity, insulin secretion and incretin effect. We will include 14 obese patients with type 2 diabetes, considered eligible to bariatric surgery according to HAS criteria, and whose diabetes treatment involves only metformin, sulfonylurea and glinides. They will be randomized to a 1-week caloric restriction period or no caloric restriction, immediately before surgery. Test meals with dosages of blood glucose, insulin, C-peptide, adiponectin, leptin, GLP-1, PYY and ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month and 12 month after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm with caloric restriction | Experimental | Other: Caloric restrictionPatients in this arm will have, during 7 days before surgery, a caloric restriction of 1000 kcal per day compared to the usual food intake. They will be hospitalized during this period. Intervention: caloric restriction |
| Arm without caloric restriction | Experimental | Other: No caloric restrictionPatients in this arm will not have a caloric restriction before surgery. Intervention: No caloric restriction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- written informed consent
- Age between 18-65 years (inclusive)
- Men or women receiving effective contraception, postmenopausal or sterile
- type 2 diabetes treated with no drugs or oral anti-diabetic agents metformin, sulfonylurea or glinides
- Body mass index 35 kg / m² or above
Key exclusion criteria (9 listed)
- Treatment of diabetes with GLP1 analogues, DPP-IV (dipeptidyl-peptidase IV) or insulin
- Treatment with drugs that modify glucose homeostasis: glucocorticoids, anorexigens, antihistaminics, psychotropic drugs especially serotonergic antidepressants (except for the occasional use of a hypnotic or anxiolytic), atropine, laxatives, thyroid hormones (with the exception of a substitution dose ensuring a stable euthyroid at baseline), beta blockers, diuretics
- Pregnancy, intention of being pregnant, breastfeeding.
- Inability to understand the nature and aims of the study or to communicate with the investigator- High probability of non
- compliance with the protocol
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 |
|---|---|---|
| Caloric restrictionCaloric restriction of 1000 kcal per day compared to the usual food intake. * usual breakfast of the patient (possibly limited in quantity) * midday and evening meals from mixed and dehydrated meals, soups with protein and dairy desserts sweetened | Other | Arm with caloric restriction |
| No caloric restrictionNo change in eating habits to patients in this arm | Other | Arm without caloric restriction |
Primary outcome
Change of area under the curve of post prandial glycemia
Time frame: Baseline to day 7 after surgery
1 secondary outcome
Change in insulin sensitivity, Change in insulin secretion, Change in incretins
Time frame: Blood samples at D-15, D-7 before surgery, D7, D80, D170, D350 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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. This study is not recruiting at the moment.
Florence GALTIER, MD contact
Eric RENARD, PU-PH contact
Florence GALTIER, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction and No caloric restriction in people with Severe Obesity and Type 2 Diabetes, run by University Hospital, Montpellier 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence GALTIER, MD (f-galtier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of area under the curve of post prandial glycemia (time frame: Baseline to day 7 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 3 Dec 2014.