Influence of Bariatric Surgery on Serum Levels of 26RFa

Obesity Clinical Trial

— RFa-Ba-S  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01982019
• Other study ID #: 2012/129/HP
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 4, 2014
• Est. completion date: July 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Rouen	Rouen	Haute Normandie

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 )
Secondary	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 )
Secondary	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
Secondary	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)