Clinical trial NCT01982019: Influence of Bariatric Surgery on Serum Levels of 26RFa
Official title: Determination of Serum Levels of the Orexigenic Neuropeptide 26RFa in Obese Female Patients With or Without Diabetes. Influence of Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Obesity
Keywords: 26RFa
sleeve gastrectomy
diabetes
obesity
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2013-11-13
Enrollment: 59
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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 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.

Primary outcomes:
measure: Serum 26RFa levels
timeFrame: About 1 month before a sleeve gastrectomy
Secondary outcomes:
measure: Kinetics of 26RFa levels during a test meal
timeFrame: Before (about 1 month) and after a sleeve gastrectomy (D30 and D180), during a test meal (T0, T30, T60, T90, T120, T150 and T180 )
measure: kinetics of classical hormones implicated in glucose control and obesity
timeFrame: Before (about 1 month) and after a sleeve gastrectomy (D30 and D180), during a test meal (T0, T30, T60, T90, T120, T150 and T180 )
measure: Levels of 26RFa and classical hormones implicated in glucose control and obesity just after a sleeve gastrectomy
timeFrame: at D3 after a sleeve gastrectomy
measure: score of satiety
timeFrame: Before (about 1 month) and after a sleeve gastrectomy (D3, D30 and D180)
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital Rouen
state: Haute Normandie
Study officials:
affiliation: University Hospital, Rouen
name: Gaëtan Prevost, MD
role: PRINCIPAL_INVESTIGATOR
References: