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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Diabetes
• Intervention / Treatment: Behavioral: Meal test taking and hormones measure including 26RFa

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Haute Normandie
    • Rouen, Haute Normandie, France, 76000
      • University Hospital Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum 26RFa levels	Serum 26RFa levels will be measured in fasting conditions before a sleeve gastrectomy in obese patients with or without diabetes.	About 1 month before a sleeve gastrectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetics of 26RFa levels during a test meal	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.	Before (about 1 month) and after a sleeve gastrectomy (D30 and D180), during a test meal (T0, T30, T60, T90, T120, T150 and T180 )
kinetics of classical hormones implicated in glucose control and obesity	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.	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 and classical hormones implicated in glucose control and obesity just 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.	at D3 after a sleeve gastrectomy
score of satiety	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.	Before (about 1 month) and after a sleeve gastrectomy (D3, D30 and D180)

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Gaëtan Prevost, MD, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2014
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: diabetes; obesity; sleeve gastrectomy; 26RFa
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 2012/129/HP