NCT01982019

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 4, 2014

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2020

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

6.4 years

First QC Date

October 16, 2013

Last Update Submit

February 5, 2026

Conditions

DiabetesObesity

Keywords

26RFasleeve gastrectomydiabetesobesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Kinetics of 26RFa levels during a test meal

    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

    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

    at D3 after a sleeve gastrectomy

  • score of satiety

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

Study Arms (3)

Obese patients with type 2 diabetes

OTHER

Meal test taking and hormones measure including 26RFa

Behavioral: Meal test taking and hormones measure including 26RFa

Obese patients witout diabetes

OTHER

Meal test taking and hormones measure including 26RFa

Behavioral: Meal test taking and hormones measure including 26RFa

healthy volonteers

OTHER

Meal test taking and hormones measure including 26RFa

Behavioral: Meal test taking and hormones measure including 26RFa

Interventions

Meal test taking and hormones measure including 26RFaBEHAVIORAL

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

Obese patients with type 2 diabetesObese patients witout diabeteshealthy volonteers

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • HbA1c \>11 %.
  • Healthy volunteers :
  • ≤ 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
  • severe medical or surgical history, particularly endocrine or cardiac,
  • oedema syndrome,
  • hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Rouen

Rouen, Haute Normandie, 76000, France

Location

Related Publications (1)

  • 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.

    PMID: 39350486DERIVED

MeSH Terms

Conditions

Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gaëtan Prevost, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2013

First Posted

November 13, 2013

Study Start

February 4, 2014

Primary Completion

June 29, 2020

Study Completion

June 29, 2020

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

FR(1)