Clinical Trial: Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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).


Sponsor: University Hospital, Bordeaux

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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 indirec

    Original Secondary Outcome: Same as current

    Information By: University Hospital, Bordeaux

    Dates:
    Date Received: June 24, 2016
    Date Started: December 2016
    Date Completion: April 2017
    Last Updated: December 23, 2016
    Last Verified: December 2016