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Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage
Lead sponsor
Asset
Exenatide
GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
10
estimated
Study population
Diabetes (other / unspecified), Hypothalamic / syndromic obesity, Obesity / overweight
Key I/E criterion
—
Primary endpoints
•Body weight, absolute change (kg)•BMI, change•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (13)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
6 endpointsChange in body weight frome baseline to end of the study.
Time frame:3 months
Body weight, absolute change (kg)
change from baseline, improvement
BMI
Time frame:baseline and 3 months
BMI, change
change from baseline, improvement
Waistline
Time frame:baseline and 3 months
Waist circumference, change
change from baseline, improvement
Ratio of body fat
Time frame:baseline and 3 months
Total fat mass
ratio, improvement
Hipline.
Time frame:baseline and 3 months
change from baseline, improvement
waistline/hipline ratio
Time frame:baseline and 3 months
ratio, improvement
Glycemic / diabetes
4 endpointsHbA1c
Time frame:baseline and 3 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Blood glucose level.
Time frame:3 months.
descriptive, improvement
Beta cell function.
Time frame:baseline and 3 months
descriptive
Insulin sensitivity.
Time frame:baseline and 3 months
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Other clinical outcomes
1 endpointGrade of metabolic equivalents (MET) scales
Time frame:baseline and 3 months
change from baseline, improvement
Other (unclassified)
2 endpointsThe amount of daily energy intake
Time frame:baseline and 3 months
change from baseline, descriptive
Resting energy expenditure (kcals per day)
Time frame:baseline and 3 months
change from baseline, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.