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

What Was Tested

This registered not phased trial tested Exenatide.

The purpose of this study is to examine the effect of exenatide on body weight and glycemic control in subjects with obesity and/or diabetes mellitus due to hypothalamic damage.

It had 1 arm (groups): Exenatide (experimental).

The registry classes the interventions as drug.

More on the Plan

Patients with hypothalamus lesion caused by tumors in the hypothalamic region, such as craniopharyngioma and germ cell tumors, and inflammatory diseases are susceptible to develop severe obesity and diabetes mellitus.

However, diet and exercise intervention has been proven useless in previous studies.

Who Took Part

The registry lists 10 planned participants were the target.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be between 18 and 55 years old;. Greater than 6 months post-treatment (including surgery, radiotherapy or chemotherapy) of craniopharyngioma or other diseases in the hypothalamic region;. BMI≧28kg/m2 and/or diabetes mellitus;. Greater than 3 months after adequate replacement therapy for hypothalamic-pituitary-adrenal (HPA) axis and hypothalamic-pituitary-thyroid (HPT) axis;. Sign informed consent document.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: less than 6 months post surgery or radiotherapy or chemotherapy for craniopharyngioma or other diseases in the hypothalamic region;; use of weight loss drugs or initiation of a weight loss program within past 3 months;; use of glp-1 agonists or analogues or dipeptidyl peptidase iv (dpp-iv) inhibitors within past 3 months;.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-12 with completion listed for 2015-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in body weight frome baseline to end of the study (time frame: 3 months). BMI (time frame: baseline and 3 months). HbA1c (time frame: baseline and 3 months).

It also tracked 7 secondary outcomes, for example Waistline, Ratio of body fat, The amount of daily energy intake, Resting energy expenditure (kcals per day), Grade of metabolic equivalents (MET) scales and Hipline.

What This Means in Plain Language

Put simply, this is a not phased trial of Exenatide in 10 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.