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Trial record 11 of 102 for:    "Craniopharyngioma"

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

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ClinicalTrials.gov Identifier: NCT02860923
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE June 24, 2016
First Posted Date  ICMJE August 9, 2016
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE January 11, 2017
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02860923 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
  • 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).
  • Assess eating behaviour thanks to physiological parameters [ Time Frame: 6 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    The energy expenditure will be estimated thanks to: - Resting metabolic rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Official Title  ICMJE Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Brief 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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Craniopharyngiomas
  • Hypothalamic Obesity
Intervention  ICMJE
  • Drug: Exenatide
  • Drug: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Exenatide
  • Placebo Comparator: Placebo
    Patients will be maintained on placebo (injected subcutaneously, twice a day) with the same dose and frequency than exenatide arm.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2016)
50
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02860923
Other Study ID Numbers  ICMJE CHUBX 2012/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Paul Perez, Dr University Hospital, Bordeaux
Principal Investigator: Blandine Gatta-Cherifi, Pr University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP