Diabetes Mellitus Clinical Trial
Official title:
Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | July 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Endocrinology and Metabolism | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in body weight frome baseline to end of the study. | 3 months | No | |
Primary | BMI | baseline and 3 months | No | |
Primary | HbA1c | baseline and 3 months | No | |
Primary | Blood glucose level. | 3 months. | No | |
Primary | Beta cell function. | baseline and 3 months | No | |
Primary | Insulin sensitivity. | baseline and 3 months | No | |
Secondary | Waistline | baseline and 3 months | No | |
Secondary | Ratio of body fat | baseline and 3 months | No | |
Secondary | The amount of daily energy intake | baseline and 3 months | No | |
Secondary | Resting energy expenditure (kcals per day) | baseline and 3 months | No | |
Secondary | Grade of metabolic equivalents (MET) scales | baseline and 3 months | No | |
Secondary | Hipline. | baseline and 3 months | No | |
Secondary | waistline/hipline ratio | baseline and 3 months | No |
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