Influence of Bariatric Surgery on Serum Levels of 26RFa

NCT ID: NCT01982019

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-04

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Diabetes Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Obese patients with type 2 diabetes

Meal test taking and hormones measure including 26RFa

Group Type OTHER

Meal test taking and hormones measure including 26RFa

Intervention Type BEHAVIORAL

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

Obese patients witout diabetes

Meal test taking and hormones measure including 26RFa

Group Type OTHER

Meal test taking and hormones measure including 26RFa

Intervention Type BEHAVIORAL

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

healthy volonteers

Meal test taking and hormones measure including 26RFa

Group Type OTHER

Meal test taking and hormones measure including 26RFa

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Obese patients (with or without type 2 diabetes) with a planned sleeve gastrectomy

* 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

* HbA1c \>11 %.
2. Healthy volunteers :


* severe medical or surgical history, particularly endocrine or cardiac,
* oedema syndrome,
* hypertension.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gaëtan Prevost, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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University Hospital Rouen

Rouen, Haute Normandie, France

Site Status

Countries

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France

References

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Khiar H, Leveque E, Lopez AG, Moreau-Grange L, Richard L, Brunel V, Perdrix A, Takhlidjt S, Devere M, Tavolacci MP, Houivet E, Huet E, Degrimaudet B, Travers C, Leprince J, Picot M, Chartrel N, Prevost G. Serum levels of the incretin-like peptide 26RFa are diminished in women living with obesity and diabetes and restored after sleeve gastrectomy: Results from the prospective pilot RFa-Ba-S study. Diabetes Obes Metab. 2024 Dec;26(12):5556-5568. doi: 10.1111/dom.15871. Epub 2024 Sep 30.

Reference Type DERIVED
PMID: 39350486 (View on PubMed)

Other Identifiers

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2012/129/HP

Identifier Type: -

Identifier Source: org_study_id

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