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

University Hospital, Rouen

Status: Completed

Conditions: Diabetes; Obesity

Treatments: Behavioral: Meal test taking and hormones measure including 26RFa

Study type: Interventional

Funder types: Other

Identifiers

NCT01982019

2012/129/HP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 3 patient groups

Obese patients with type 2 diabetes

Other group

Description:

Meal test taking and hormones measure including 26RFa

Treatment:

Behavioral: Meal test taking and hormones measure including 26RFa

Obese patients witout diabetes

Other group

Description:

Meal test taking and hormones measure including 26RFa

Treatment:

Behavioral: Meal test taking and hormones measure including 26RFa

healthy volonteers

Other group

Description:

Meal test taking and hormones measure including 26RFa

Treatment:

Behavioral: Meal test taking and hormones measure including 26RFa