Hypothalamic Obesity Clinical Trial
— CRANIOEXEOfficial title:
Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Verified date | October 2018 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02849743 -
Intranasal Oxytocin in Hypothalamic Obesity
|
Phase 2 | |
Recruiting |
NCT06217848 -
The Effect of GLP-1 Agonist in Patients With Hypothalamic Obesity: Prospective, Pilot Study
|
Early Phase 1 | |
Withdrawn |
NCT05147415 -
Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)
|
Phase 2 | |
Completed |
NCT00892073 -
Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy
|
Phase 2 | |
Not yet recruiting |
NCT06299891 -
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
|
Phase 2 | |
Recruiting |
NCT06239116 -
A Study of RM-718 in Healthy Subjects and in Patients With HO
|
Phase 1 | |
Completed |
NCT02664441 -
Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity
|
Phase 3 | |
Completed |
NCT04725240 -
Open-Label Study of Setmelanotide in Hypothalamic Obesity
|
Phase 2 | |
Completed |
NCT03673813 -
A Personalized Program of Physical Activity and Diet for Hypothalamic Obesity
|
||
Not yet recruiting |
NCT06046443 -
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
|
Phase 2 | |
Withdrawn |
NCT03708913 -
Neuromodulation for Hypothalamic Obesity
|
N/A | |
Completed |
NCT01061775 -
Effects of Exenatide on Hypothalamic Obesity
|
Phase 1/Phase 2 | |
Completed |
NCT00171613 -
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
|
Phase 4 | |
Recruiting |
NCT01783717 -
Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage
|
N/A | |
Enrolling by invitation |
NCT05774756 -
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
|
Phase 3 | |
Completed |
NCT05319301 -
Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)
|
N/A |