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NCT Number: NCT01982019

Influence of Bariatric Surgery on Serum Levels of 26RFa

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.

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Key information

Conditions

Diabetes Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Rouen

Rouen, Haute Normandie, 76000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Patients :
  • Inclusion Criteria:
  • Obese patients (with or without type 2 diabetes) with a planned sleeve gastrectomy
  • Exclusion Criteria:
  • HbA1c >11 %.
  • Healthy volunteers :
  • 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
  • Exclusion Criteria:
  • severe medical or surgical history, particularly endocrine or cardiac,
  • oedema syndrome,
  • hypertension.

Treatment and study plan

Meal test taking and hormones measure including 26RFa

Behavioral

Meal test taking and blood sampling for the measure of 26RFa and classical hormones implicated in glucose control and obesity

Primary outcomes

  1. Serum 26RFa levels

    Time frame: About 1 month before a sleeve gastrectomy

    Serum 26RFa levels will be measured in fasting conditions before a sleeve gastrectomy in obese patients with or without diabetes.

Secondary outcomes

  1. 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 )

    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.

  2. 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 )

    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.

  3. 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

    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.

  4. score of satiety

    Time frame: Before (about 1 month) and after a sleeve gastrectomy (D3, D30 and D180)

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Determination of Serum Levels of the Orexigenic Neuropeptide 26RFa in Obese Female Patients With or Without Diabetes. Influence of Bariatric Surgery

Acronym: RFa-Ba-S

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2013
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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