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Trial record 73 of 399 for:    PYY

SLEEVEDIAB To Explore the Early and Late Metabolic Effects of Sleeve Gastrectomy in Obese Patients (SLEEVEDIAB)

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ClinicalTrials.gov Identifier: NCT02076880
Recruitment Status : Unknown
Verified September 2013 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : March 4, 2014
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Severe Obesity Type 2 Diabetes Other: Caloric restriction Other: No caloric restriction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigation of Endocrin-metabolic Modifications Related to Diabetes Improvement After Sleeve Gastrectomy in Severly Obese
Study Start Date : November 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm with caloric restriction

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

Other: Caloric restriction

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

Experimental: Arm without caloric restriction

Patients in this arm will not have a caloric restriction before surgery.

Intervention: No caloric restriction

Other: No caloric restriction
No change in eating habits to patients in this arm




Primary Outcome Measures :
  1. Change of area under the curve of post prandial glycemia [ Time Frame: Baseline to day 7 after surgery ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • No affiliation to the French social security
  • Loss of personal capacity resulting in state protection
  • Deprivation of liberty by judicial or administrative decision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076880


Contacts
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Contact: Florence GALTIER, MD f-galtier@chu-montpellier.fr
Contact: Eric RENARD, PU-PH e-renard@chu-montpellier.fr

Locations
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France
CHU Montpellier Recruiting
Montpellier, France, 34295
Contact: GALTIER Florence       f-galtier@chu-montpellier.fr   
Principal Investigator: GALTIER Florence, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Florence GALTIER, MD Montpellier University Hospital

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02076880     History of Changes
Other Study ID Numbers: 9016
2012-A00962-41 ( Other Identifier: ID-RCB - ANSM )
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: September 2013

Keywords provided by University Hospital, Montpellier:
Type 2 diabetes
Obesity
Sleeve gastrectomy
Insulin
GLP-1

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Obesity, Morbid
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms