Diabetes, Obesity
Conditions
Keywords
26RFa, sleeve gastrectomy, diabetes, obesity
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.
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.
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
Sponsors
University Hospital, Rouen
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum 26RFa levels | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 ) | 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. |
| 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 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. |
| Levels of 26RFa and classical hormones implicated in glucose control and obesity just after a sleeve gastrectomy | at D3 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. |
| score of satiety | Before (about 1 month) and after a sleeve gastrectomy (D3, D30 and D180) | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGaëtan Prevost, MD
University Hospital, Rouen
Outcome results
None listed