Influence of Bariatric Surgery on Serum Levels of 26RFa (RFa-Ba-S)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01982019
First received: October 16, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

The 26RFa was recently discovered in the hypothalamus. In rodents it seems to be related to glucose metabolism and obesity. However, no data exists in obese patients or in patients with diabetes. Thus, the investigators planned to dose 26RFa level in obese patients before and after a sleeve gastrectomy in order to study the effect of a weight loss on its levels. The investigators will also dose 26RFa concentrations in obese patients with type 2 diabetes and in healthy volunteers with normal weight. Comparison of these different groups will permit us to better understand the 26RFa involvement in glucose concentration regulation and in obesity.


Condition Intervention
Diabetes
Obesity
Behavioral: Meal test taking and hormones measure including 26RFa

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Determination of Serum Levels of the Orexigenic Neuropeptide 26RFa in Obese Female Patients With or Without Diabetes. Influence of Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Serum 26RFa levels [ Time Frame: About 1 month before a sleeve gastrectomy ] [ Designated as safety issue: No ]
    Serum 26RFa levels will be measured in fasting conditions before a sleeve gastrectomy in obese patients with or without diabetes.


Secondary Outcome Measures:
  • Kinetics of 26RFa levels during a test meal [ Time Frame: Before (about 1 month) and after a sleeve gastrectomy (D30 and D180), during a test meal (T0, T30, T60, T90, T120, T150 and T180 ) ] [ Designated as safety issue: No ]
    levels of 26RFa levels will be measured during a meal test before and after a sleeve gastrectomy in obese patients with or without diabetes, and once a time in healthy volunteers.

  • kinetics of classical hormones implicated in glucose control and obesity [ Time Frame: Before (about 1 month) and after a sleeve gastrectomy (D30 and D180), during a test meal (T0, T30, T60, T90, T120, T150 and T180 ) ] [ Designated as safety issue: No ]
    levels of classical hormones implicated in glucose control and obesity will be measured during a meal test before and after a sleeve gastrectomy in obese patients with or without diabetes, and once a time in healthy volunteers.

  • Levels of 26RFa and classical hormones implicated in glucose control and obesity just after a sleeve gastrectomy [ Time Frame: at D3 after a sleeve gastrectomy ] [ Designated as safety issue: No ]
    Levels of 26RFa and classical hormones implicated in glucose control and obesity just after a sleeve gastrectomy (D3) in obese patients with or without diabetes.

  • score of satiety [ Time Frame: Before (about 1 month) and after a sleeve gastrectomy (D3, D30 and D180) ] [ Designated as safety issue: No ]
    Score satiety will be calculated using a questionary before and after a sleeve gastrectomy : once a time at D3, and at T0, T90 and T180 during a meal test at D30 and D180, in obese patients with or without diabetes. It will be also calculated in healthy volunteers at T0, T90 and T180 during a test meal.


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Obese patients with type 2 diabetes
Meal test taking and hormones measure including 26RFa
Behavioral: Meal test taking and hormones measure including 26RFa
Meal test taking and blood sampling for the measure of 26RFa and classical hormones implicated in glucose control and obesity
Obese patients witout diabetes
Meal test taking and hormones measure including 26RFa
Behavioral: Meal test taking and hormones measure including 26RFa
Meal test taking and blood sampling for the measure of 26RFa and classical hormones implicated in glucose control and obesity
healthy volonteers
Meal test taking and hormones measure including 26RFa
Behavioral: Meal test taking and hormones measure including 26RFa
Meal test taking and blood sampling for the measure of 26RFa and classical hormones implicated in glucose control and obesity

Detailed Description:

The 26RFa is an orexigenic neuropeptide of the Rfamides family, localized in two hypothalamic nuclei. Its increase induced obesity and it is elevated in obese rodents. In addition, in human, it is elevated in anorexic patients. However, no data exists in obese patients or in patients with diabetes. Thus, the investigators planned to measure 26RFa level in obese patients before and after a sleeve gastrectomy in order to study the effect of a weight loss on its levels. The investigators will also dose 26RFa concentrations in obese patients with type 2 diabetes and in healthy volunteers with normal weight. Comparison of these different groups will permit us to better understand the 26RFa involvement in glucose concentration regulation and in obesity.

The investigators will also measure other hormones known to have a major role in glucose metabolism and obesity (ie. insulin, adiponectin).

A meal test will be given to the volunteers in order to study the kinetics' of these molecules during and after food intake.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  1. Patients :

    1. Inclusion Criteria:

      • Obese patients (with or without type 2 diabetes) with a planned sleeve gastrectomy
    2. Exclusion Criteria:

      • HbA1c >11 %.
  2. Healthy volunteers :

    1. Inclusion Criteria:

      • 20 ≤ BMI ≤ 25 kg/m²,
      • with no treatment that may influence the glycemic control,
      • normal electrocardiogram,
      • no disturbance of the following blood tests: CBC, serum electrolytes, glucose,
      • negative serology of HIV, hepatitis B and C,
      • does not participate at another clinical trial in the last 3 months
    2. Exclusion Criteria:

      • severe medical or surgical history, particularly endocrine or cardiac,
      • oedema syndrome,
      • hypertension.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982019

Contacts
Contact: Gaëtan Prevost, MD 0033(0)232889081 gaetan.prevost@chu-rouen.fr

Locations
France
University Hospital Rouen Recruiting
Rouen, Haute Normandie, France, 76000
Principal Investigator: Gaëtan Prevost, MD         
Sub-Investigator: Antoine Gancel, MD         
Sub-Investigator: Anne F Cailleux, MD         
Sub-Investigator: Michel Scotte, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Gaëtan Prevost, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01982019     History of Changes
Other Study ID Numbers: 2012/129/HP
Study First Received: October 16, 2013
Last Updated: June 18, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Rouen:
26RFa
sleeve gastrectomy
diabetes
obesity

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014