Trial · Interventional

CompletedPhase 3Registry data

Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

Short name CRANIOEXE

NCTNCT02860923Other idCHUBX 2012/17Other id2013-004755-21

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 42 participants (actual)
Sponsor: University Hospital, Bordeaux · Other
Design: Randomized · Double masking
Countries: 1 country
France
Start: 11 Jan 2017
Primary completion: 30 Jun 2018
Completion: 30 Sept 2018
First posted: 9 Aug 2016 (estimated)
Last update posted: 22 May 2026
Conditions: Craniopharyngiomas · Hypothalamic Obesity

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 3
CRANIOEXE
NCT02860923
11 Jan 2017 to 30 Sept 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ExenatideDrug
PlaceboDrug

Arms2

Experimental
Exenatide
Treatment with exenatide at the initial dose of 5 µg x 2/day (subcutaneously administered) during 4 weeks, and treatment with 10 µg x 2/day during 5 months.
Placebo comparator
Placebo
Patients will be maintained on placebo (injected subcutaneously, twice a day) with the same dose and frequency than exenatide arm.

Primary outcomes1

Outcomes the sponsor listed as primary.

Compare body weight change thanks to weighing machine
Time frame · baseline and 6 months
Registry description
The primary outcome will be assessed by a weighing machine that measure until 200 kg.

Secondary outcomes(18)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

4 results

Impact of exenatide on weight loss and eating behavior in adults with craniopharyngioma-related obesity: the CRANIOEXE randomized placebo-controlled trial.

Gatta-Cherifi et al. 2024European journal of endocrinologycited by 19

PMID 38450721DOI 10.1093/ejendo/lvae024PUB-38450721

Rights unknown4 results

Source link See results (4)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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