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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-11

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage

NCT01783717

Hypothalamic Obesity Diabetes Mellitus

UNKNOWN NA

Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue

NCT01794429

Obesity Metabolic Syndrome X Drug-induced Obesity +1 more

COMPLETED PHASE3

An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy

NCT00677313

Lipodystrophy

COMPLETED NA

Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)

NCT04897802

Hypopituitarism Central Diabetes Insipidus Panhypopituitarism +5 more

COMPLETED PHASE4

The Effect of GLP-1 Receptor Activation on Central Reward and Satiety in Obesity and Diabetes

NCT01281228

Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Craniopharyngiomas Hypothalamic Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

Placebo

Patients will be maintained on placebo (injected subcutaneously, twice a day) with the same dose and frequency than exenatide arm.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exenatide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No