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Status unknownNCT01783717Updated Oct 22, 2013

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

An interventional study of Exenatide in Hypothalamic Obesity and Diabetes Mellitus, sponsored by Huashan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-10-22.

Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

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. The occurrence of hypothalamic obesity in patients after surgery with or without radiotherapy for craniopharyngioma can be as high as 42-66%, and the incidence of type 2 diabetes mellitus of them is twice as much as healthy controls. Treatment of obesity and diabetes mellitus in this population is crucial for increasing morbidity and mortality. However, diet and exercise intervention has been proven useless in previous studies. Safe and effective medicine remains to be developed. Exenatide, a GLP-1 receptor agonist, which play an antihyperglycemic role through a variety of mechanisms, such as enhancing glucose-dependent insulin secretion, increasing beta cell mass and decreasing glucagon secretion, possesses a potent ability to induce satiety, slow gastric emptying and reduce food intake, resulting in weight loss both in diabetics and patients with simple obesity. Previous animal study has already shown GLP-1 agonist exendin-4 leads to reduction of weight and caloric intake in a rat model of hypothalamic obesity. Therefore, the investigators hypothesize exenatide treatment might lead to weight loss in hypothalamic obese patients and improve their glycemic control.

02

Conditions studied

  • Hypothalamic Obesity
  • Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 10 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Exenatide

    5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks

    Drug: Exenatide

Interventions

  • DrugExenatide

    5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks

    Also known as: Byetta

06

What researchers measure

Primary outcomes

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

    Time frame: 3 months

  2. BMI

    Time frame: baseline and 3 months

  3. HbA1c

    Time frame: baseline and 3 months

  4. Blood glucose level.

    Time frame: 3 months.

  5. Beta cell function.

    Time frame: baseline and 3 months

  6. Insulin sensitivity.

    Time frame: baseline and 3 months

Secondary outcomes

  1. Waistline

    Time frame: baseline and 3 months

  2. Ratio of body fat

    Time frame: baseline and 3 months

  3. The amount of daily energy intake

    Time frame: baseline and 3 months

  4. Resting energy expenditure (kcals per day)

    Time frame: baseline and 3 months

  5. Grade of metabolic equivalents (MET) scales

    Time frame: baseline and 3 months

  6. Hipline.

    Time frame: baseline and 3 months

  7. waistline/hipline ratio

    Time frame: baseline and 3 months

07

Study locations

1 of 1 sites recruiting
  • Department of Endocrinology and Metabolism
    Shanghai, Shanghai 200040, China
    • Ye h ying · Contact · 86-21-52887027
    • Zhang z yun · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01783717
Lead sponsor
Huashan Hospital
Responsible party
Zhaoyun Zhang (Clinical Professor, Huashan Hospital) — Principal investigator
First posted
Feb 5, 2013
Start date
Dec 2012
Primary completion
Jan 2015 (estimated)
Completion
Jul 2015 (estimated)
Last update
Oct 22, 2013

Study contacts

Zhang z yun
Contact
86-21-52888286
Li yi ming
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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