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

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Treatments: Exenatide

Criteria

Inclusion Criteria:

1. Be between 18 and 55 years old;

2. Greater than 6 months post-treatment (including surgery, radiotherapy or chemotherapy) of craniopharyngioma or other diseases in the hypothalamic region;

3. BMI≧28kg/m2 and/or diabetes mellitus;

4. Greater than 3 months after adequate replacement therapy for hypothalamic-pituitary-adrenal (HPA) axis and hypothalamic-pituitary-thyroid (HPT) axis;

5. Sign informed consent document.

Exclusion Criteria:

1. Less than 6 months post surgery or radiotherapy or chemotherapy for craniopharyngioma or other diseases in the hypothalamic region;

2. Inadequate replacement for the HPA axis and HPT axis or undertaking adjustments of the kind or dose of the substitutive medicine;

3. Use of weight loss drugs or initiation of a weight loss program within past 3 months;

4. Use of GLP-1 agonists or analogues or dipeptidyl peptidase IV (DPP-IV) inhibitors within past 3 months;

5. History of bariatric surgery;

6. Diagnosed with simple obesity or diabetes mellitus prior to the hypothalamic disorders, and those diagnosed with type 1 diabetes mellitus;

7. With end-stage-renal diseases or history of kidney transplant or complicated with acute/chronic kidney failure (GFR≦30ml/min);

8. History of inflammatory bowel diseases or gastroparesis or other gastric mortility problems;

9. History of pancreatitis or chronic cholecystitis;

10. History of allergic reaction to exenatide or other medication components;

11. Undertaking warfarin;

12. Pregnant or lactating women;

13. Are participating in, or have participated in other drug clinical trials within past 3 months.