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UnknownPhase NA

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

Lead sponsor

Huashan Hospital

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, changeHbA1c, 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

NCT IDNCT01783717
Org study ID2012-217

Timeline

Milestones

Study first posted2013-02-05estimated
Last update posted2013-10-22estimated
Study start2012-12 (month precision)
Primary completion2015-01estimated (month precision)
Study completion2015-07estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Diabetes (other / unspecified)Hypothalamic / syndromic obesityObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

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
Glycemic / diabetes
4
Other (unclassified)
2
Other clinical outcomes
1

Weight & body composition

6 endpoints
Primary/protocol endpoint

Change in body weight frome baseline to end of the study.

Time frame:3 months

Body weight, absolute change (kg)

change from baseline, improvement

Primary/protocol endpoint

BMI

Time frame:baseline and 3 months

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waistline

Time frame:baseline and 3 months

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Ratio of body fat

Time frame:baseline and 3 months

Total fat mass

ratio, improvement

Secondary/protocol endpoint

Hipline.

Time frame:baseline and 3 months

change from baseline, improvement

Secondary/protocol endpoint

waistline/hipline ratio

Time frame:baseline and 3 months

ratio, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

HbA1c

Time frame:baseline and 3 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint/low confidence

Blood glucose level.

Time frame:3 months.

descriptive, improvement

Primary/protocol endpoint/low confidence

Beta cell function.

Time frame:baseline and 3 months

descriptive

Primary/protocol endpoint

Insulin sensitivity.

Time frame:baseline and 3 months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Grade of metabolic equivalents (MET) scales

Time frame:baseline and 3 months

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

The amount of daily energy intake

Time frame:baseline and 3 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Resting energy expenditure (kcals per day)

Time frame:baseline and 3 months

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.