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Trial record 3 of 6 for:    "Hypothalamic Obesity" | "Hormones"

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

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.


Condition or disease Intervention/treatment Phase
Craniopharyngiomas Hypothalamic Obesity Drug: Exenatide Drug: Placebo Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Actual Study Start Date : January 11, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : September 30, 2018


Arm Intervention/treatment
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.
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.
Drug: Placebo



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Treatment tolerance thanks to digestive parameters [ Time Frame: 6 months ]

    Tolerance will be assessed by the presence of:

    - Nauseas, vomiting.


  2. Treatment tolerance thanks to dermatologic parameter [ Time Frame: 6 months ]

    Tolerance will be assessed by the presence of:

    - Injection-site symptoms.


  3. Treatment tolerance thanks to pulse rate [ Time Frame: 6 months ]

    Tolerance will be assessed by the presence of :

    - Increasing of pulse rate.


  4. Treatment tolerance thanks to Beck scale [ Time Frame: 6 months ]

    Tolerance will be assessed by the presence of :

    - Anxiety by Beck scale.


  5. Treatment tolerance thanks to HAD scale [ Time Frame: 6 months ]

    Tolerance will be assessed by the presence of :

    - depression evaluated by HAD scale.


  6. Treatment tolerance thanks to enzymatic parameters [ Time Frame: 6 months ]

    Tolerance will be assessed by the presence of :

    - Increasing of pancreatic enzymes.


  7. Treatment tolerance thanks to glycemia parameter [ Time Frame: 6 months ]

    Tolerance will be assessed by the presence of :

    - Hypoglycaemia


  8. Assess cardiovascular risks thanks to glucose profil [ Time Frame: 6 months ]
    Levels of blood glucose and insulin, oral glucose tolerance testing, haemoglobin A1C

  9. Assess cardiovascular risks thanks to lipid profil [ Time Frame: 6 months ]
    Levels of HDL cholesterol, triglycerides, LDL cholesterol.

  10. 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).


  11. 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.


  12. Assess eating behaviour thanks to energy intake [ Time Frame: 6 months ]
  13. 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).


  14. 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.


  15. 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).


  16. 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).


  17. 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).


  18. Assess energy expenditure thanks to indirect calorimetry [ Time Frame: 6 months ]

    The energy expenditure will be estimated thanks to:

    - Resting metabolic rate




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860923


Locations
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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, France
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Paul Perez, Dr University Hospital, Bordeaux
Principal Investigator: Blandine Gatta-Cherifi, Pr University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02860923     History of Changes
Other Study ID Numbers: CHUBX 2012/17
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Bordeaux:
glucagon-like peptide-1
exenatide
placebo
multicenter trial

Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Obesity
Craniopharyngioma
Adamantinoma
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins