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CompletedNCT01982019RFa-Ba-SUpdated Feb 6, 2026

Influence of Bariatric Surgery on Serum Levels of 26RFa

An interventional study of Meal test taking and hormones measure including 26RFa in Diabetes and Obesity, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Non-randomized
Ages
30 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes
  • Obesity

Keywords

  • 26RFa
  • sleeve gastrectomy
  • diabetes
  • obesity
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 62 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

  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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Other
    Obese patients with type 2 diabetes

    Meal test taking and hormones measure including 26RFa

    Behavioral: Meal test taking and hormones measure including 26RFa

  • Other
    Obese patients witout diabetes

    Meal test taking and hormones measure including 26RFa

    Behavioral: Meal test taking and hormones measure including 26RFa

  • Other
    healthy volonteers

    Meal test taking and hormones measure including 26RFa

    Behavioral: Meal test taking and hormones measure including 26RFa

Interventions

  • BehavioralMeal 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

06

What researchers measure

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.

    Time frame: About 1 month before a sleeve gastrectomy

Secondary outcomes

  1. 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.

    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 )

  2. 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.

    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 )

  3. 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.

    Time frame: at D3 after a sleeve gastrectomy

  4. 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.

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

07

Study locations

1 site
  • University Hospital Rouen
    Rouen, Haute Normandie 76000, France
08

References and documents

Publications

  • 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. PubMed 39350486 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01982019
Lead sponsor
University Hospital, Rouen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Nov 13, 2013
Start date
Feb 4, 2014
Primary completion
Jun 29, 2020
Completion
Jun 29, 2020
Last update
Feb 6, 2026

Study contacts

Gaëtan Prevost, MD
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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