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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02860923
Other study ID # CHUBX 2012/17
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 11, 2017
Est. completion date September 30, 2018

Study information

Verified date October 2018
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date September 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
Exenatide

Placebo


Locations

Country Name City State
France 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

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare body weight change thanks to weighing machine The primary outcome will be assessed by a weighing machine that measure until 200 kg. baseline and 6 months
Secondary Treatment tolerance thanks to digestive parameters Tolerance will be assessed by the presence of:
- Nauseas, vomiting.
6 months
Secondary Treatment tolerance thanks to dermatologic parameter Tolerance will be assessed by the presence of:
- Injection-site symptoms.
6 months
Secondary Treatment tolerance thanks to pulse rate Tolerance will be assessed by the presence of :
- Increasing of pulse rate.
6 months
Secondary Treatment tolerance thanks to Beck scale Tolerance will be assessed by the presence of :
- Anxiety by Beck scale.
6 months
Secondary Treatment tolerance thanks to HAD scale Tolerance will be assessed by the presence of :
- depression evaluated by HAD scale.
6 months
Secondary Treatment tolerance thanks to enzymatic parameters Tolerance will be assessed by the presence of :
- Increasing of pancreatic enzymes.
6 months
Secondary Treatment tolerance thanks to glycemia parameter Tolerance will be assessed by the presence of :
- Hypoglycaemia
6 months
Secondary Assess cardiovascular risks thanks to glucose profil Levels of blood glucose and insulin, oral glucose tolerance testing, haemoglobin A1C 6 months
Secondary Assess cardiovascular risks thanks to lipid profil Levels of HDL cholesterol, triglycerides, LDL cholesterol. 6 months
Secondary Assess cardiovascular risks thanks to metabolic parameters The metabolic parameters considered:
- Body composition (Dual energy-ray absorptiometry) and abdominal obesity (waist circumference).
6 months
Secondary Assess eating behaviour thanks to physiological parameters The eating behaviour will be evaluated by:
- Plasma level of ghrelin measured after an overnight fast.
6 months
Secondary Assess eating behaviour thanks to energy intake 6 months
Secondary Assess eating behaviour thanks to Three factor eating The eating behaviour will be evaluated by:
- Scores of restriction, hunger and disinhibition (French version of the Three factor Eating Questionnaire).
6 months
Secondary Assess eating behaviour thanks to visual analogic scales The eating behaviour will be evaluated by:
- Scores of desire to eat, hunger and fullness at visual analogic scales.
6 months
Secondary Assess quality of life thanks to Beck questionnaire The quality of life will be assessed by:
- Scores of depression (short questionnaire of Beck).
6 months
Secondary Assess quality of life thanks to ORWELL questionnaire The quality of life will be assessed by:
- Scores of quality of life (ORWELL questionnaire).
6 months
Secondary Assess energy expenditure thanks to physical activity The energy expenditure will be estimated thanks to pedometer.
- Resting metabolic rate (indirect calorimetry).
6 months
Secondary Assess energy expenditure thanks to indirect calorimetry The energy expenditure will be estimated thanks to:
- Resting metabolic rate
6 months
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