DRUG
Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Status
Completed
Phase
Phase 3
Enrollment
42
Locations
11
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
This hypothalamic obesity is associated with serious metabolic and psychosocial consequences. The purpose of the study is to compare the change of body weight after 6 months treatment with a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.
Full detailed description
The development of glucagon-like peptide-1 (GLP-1) analogues might be a solution since native GLP-1 suppresses appetite and energy intake in both normal weight and obese individuals as well as in people with type 2 diabetes and delays gastric emptying. The underlying mechanisms that mediate the effects of weight involve not only central regions like the hypothalamus and the solitary tractus nucleus and area postrema but also peripheral regions as the gastrointestinal tract. These extra hypothalamic effects are of particular interest in the cases of obesity due to hypothalamic lesions. Exenatide is a glucagon-like peptide-1 (GLP-1) analogue with a high structural homology to human GLP-1, a gut derived incretin hormone. Since exenatide causes a dose-dependent weight loss, decreasing concentration of glycosylated haemoglobin as well as improving ß-cell function and systolic blood pressure, it could be an attractive treatment for both type 2 diabetes and obesity. In a double-blind placebo-controlled 24-week trial, it has been recently shown that non diabetic obese patients maintained on exenatide 10µg x 2/j lost significantly more weight than did those on placebo (5.1 kg versus 1.6).
Interventions
Treatment arms and agents.
DRUG
Placebo
Timeline
From registration to results.
First posted
Aug 9, 2016
Study start
Jan 11, 2017
Primary completion
Jun 30, 2018
Study completion
Sep 30, 2018
Results posted
Not reported
Registry updated
May 22, 2026
Outcomes
What the study measures.
Primary outcomes
Compare body weight change thanks to weighing machine
Time frame · baseline and 6 months
The primary outcome will be assessed by a weighing machine that measure until 200 kg.
Secondary outcomes
Treatment tolerance thanks to digestive parameters
Time frame · 6 months
Tolerance will be assessed by the presence of: \- Nauseas, vomiting.
Treatment tolerance thanks to dermatologic parameter
Time frame · 6 months
Tolerance will be assessed by the presence of: \- Injection-site symptoms.
Treatment tolerance thanks to pulse rate
Time frame · 6 months
Tolerance will be assessed by the presence of : \- Increasing of pulse rate.
Treatment tolerance thanks to Beck scale
Time frame · 6 months
Tolerance will be assessed by the presence of : \- Anxiety by Beck scale.
Treatment tolerance thanks to HAD scale
Time frame · 6 months
Tolerance will be assessed by the presence of : \- depression evaluated by HAD scale.
Treatment tolerance thanks to enzymatic parameters
Time frame · 6 months
Tolerance will be assessed by the presence of : \- Increasing of pancreatic enzymes.
Treatment tolerance thanks to glycemia parameter
Time frame · 6 months
Tolerance will be assessed by the presence of : \- Hypoglycaemia
Assess cardiovascular risks thanks to glucose profil
Time frame · 6 months
Levels of blood glucose and insulin, oral glucose tolerance testing, haemoglobin A1C
Assess cardiovascular risks thanks to lipid profil
Time frame · 6 months
Levels of HDL cholesterol, triglycerides, LDL cholesterol.
Assess cardiovascular risks thanks to metabolic parameters
Time frame · 6 months
The metabolic parameters considered: \- Body composition (Dual energy-ray absorptiometry) and abdominal obesity (waist circumference).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * They are between 18 and 75 yrs. * They had been diagnosed with a craniopharyngioma treated by surgery and/or irradiation without sign of recurrence. * They have a BMI upper than 30kg/m² with intractable weight gain following therapy for craniopharyngioma. * They demonstrate at least one other endocrinopathy, as a marker of hypothalamic damage. * All pituitary deficiencies are correctly treated. * They gave their written, informed consent before the beginning of the study. Exclusion Criteria: * They have type 1 diabetes. * They have type 2 diabetes treated with insulin. * Acidocetosis. * Bariatric surgery * Previous personal history of thyroid or pancreatic cancer. * Hypercalcitoninemia. * They have been previously treated by GLP1 analogs. * Hypertriglyceridemia upper than 5g/l * They had previously demonstrated voluntary weight loss during the three previous months. * They are under the age of 18 years or over the age of 65 yrs. * They are maintained on medical treatment against obesity. * They are receiving supraphysiologic hydrocortisone therapy (upper than 30 mg/jour). * Their GH status change during the course of the study. * Exenatide is contraindicated. * Psychological and/or medical problems that would create difficulties for the patient to comply with the study protocol are present.
Study locations
11 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
CHU d'Angers
Angers, France
CHU de Brest
Brest, France
CHU de Grenoble
Grenoble, France
CHU de Lyon
Lyon, France
APHM
Marseille, France
Hôpital Bicêtre
Paris, France
Hôpital Cochin
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Pitié Salpétrière (APHP)
Paris, France
Hôpital Haut-Lévêque
Pessac, France
CHU de Toulouse
Toulouse, France
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