DiabetesRFa-Ba-SNCT01982019
Influence of Bariatric Surgery on Serum Levels of 26RFa
A study testing Meal test taking and hormones measure including 26RFa in people with Diabetes and Obesity, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- What is being tested?
- Meal test taking and hormones measure including 26RFa
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2014to 29 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
- Patients :
- Inclusion Criteria:
- Obese patients (with or without type 2 diabetes) with a planned sleeve gastrectomy
- Exclusion Criteria:
- HbA1c >11 %.
- Healthy volunteers :
- 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
- Exclusion Criteria:
- severe medical or surgical history, particularly endocrine or cardiac,
- oedema syndrome,
- hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Meal test taking and hormones measure including 26RFa
- Keywords
- 26RFa, sleeve gastrectomy, diabetes, obesity
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal test taking and hormones measure including 26RFaBehavioural
Meal test taking and blood sampling for the measure of 26RFa and classical hormones implicated in glucose control and obesity
| Study group | Role | What they receive |
|---|---|---|
| Obese patients with type 2 diabetes | Other | Meal test taking and hormones measure including 26RFa Receives: Behavioral: Meal test taking and hormones measure including 26RFa |
| Obese patients witout diabetes | Other | Meal test taking and hormones measure including 26RFa Receives: Behavioral: Meal test taking and hormones measure including 26RFa |
| healthy volonteers | Other | Meal test taking and hormones measure including 26RFa Receives: Behavioral: Meal test taking and hormones measure including 26RFa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 26RFa levels
Serum 26RFa levels will be measured in fasting conditions before a sleeve gastrectomy in obese patients with or without diabetes.
Measured: About 1 month before a sleeve gastrectomy
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before (about 1 month) and after a sleeve gastrectomy (D3, D30 and D180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start4 Feb 2014
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan Prevost, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982019
- Sponsor's protocol ID
- 2012/129/HP
- Acronym
- RFa-Ba-S
- Status last verified
- Feb 2026
- First submitted
- 16 Oct 2013
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Serum Levels of the Orexigenic Neuropeptide 26RFa in Obese Female Patients With or Without Diabetes. Influence of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01982019
- Acronym / sponsor ID
- RFa-Ba-S / 2012/129/HP
- Keywords
- 26RFa, sleeve gastrectomy, diabetes, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 4 Feb 2014 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese patients with type 2 diabetes | Other | Behavioral: Meal test taking and hormones measure including 26RFaMeal test taking and hormones measure including 26RFa |
| Obese patients witout diabetes | Other | Behavioral: Meal test taking and hormones measure including 26RFaMeal test taking and hormones measure including 26RFa |
| healthy volonteers | Other | Behavioral: Meal test taking and hormones measure including 26RFaMeal test taking and hormones measure including 26RFa |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal test taking and hormones measure including 26RFaMeal test taking and blood sampling for the measure of 26RFa and classical hormones implicated in glucose control and obesity | Behavioural | Obese patients with type 2 diabetes, Obese patients witout diabetes, healthy volonteers |
Primary outcome
Serum 26RFa levels
Time frame: About 1 month before a sleeve gastrectomy
Serum 26RFa levels will be measured in fasting conditions before a sleeve gastrectomy in obese patients with or without diabetes.
4 secondary outcomes
Kinetics of 26RFa levels during a test meal
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 )
kinetics of classical hormones implicated in glucose control and obesity
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 )
Levels of 26RFa and classical hormones implicated in glucose control and obesity just after a sleeve gastrectomy
Time frame: at D3 after a sleeve gastrectomy
score of satiety
Time frame: Before (about 1 month) and after a sleeve gastrectomy (D3, D30 and D180)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 39350486Khiar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaëtan Prevost, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal test taking and hormones measure including 26RFa in people with Diabetes and Obesity, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 26RFa levels (time frame: About 1 month before a sleeve gastrectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.