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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Zhaoyun Zhang, Huashan Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Zhaoyun Zhang, Huashan Hospital Identifier:
First received: December 25, 2012
Last updated: October 20, 2013
Last verified: October 2013
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.

Condition Intervention
Hypothalamic Obesity Diabetes Mellitus Drug: Exenatide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage

Resource links provided by NLM:

Further study details as provided by Zhaoyun Zhang, Huashan Hospital:

Primary Outcome Measures:
  • Change in body weight frome baseline to end of the study. [ Time Frame: 3 months ]
  • BMI [ Time Frame: baseline and 3 months ]
  • HbA1c [ Time Frame: baseline and 3 months ]
  • Blood glucose level. [ Time Frame: 3 months. ]
  • Beta cell function. [ Time Frame: baseline and 3 months ]
  • Insulin sensitivity. [ Time Frame: baseline and 3 months ]

Secondary Outcome Measures:
  • Waistline [ Time Frame: baseline and 3 months ]
  • Ratio of body fat [ Time Frame: baseline and 3 months ]
  • The amount of daily energy intake [ Time Frame: baseline and 3 months ]
  • Resting energy expenditure (kcals per day) [ Time Frame: baseline and 3 months ]
  • Grade of metabolic equivalents (MET) scales [ Time Frame: baseline and 3 months ]
  • Hipline. [ Time Frame: baseline and 3 months ]
  • waistline/hipline ratio [ Time Frame: baseline and 3 months ]

Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks
Drug: Exenatide
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks
Other Name: Byetta

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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01783717

Contact: Zhang z yun 86-21-52888286

China, Shanghai
Department of Endocrinology and Metabolism Recruiting
Shanghai, Shanghai, China, 200040
Contact: Ye h ying    86-21-52887027      
Sub-Investigator: Zhang z yun         
Sponsors and Collaborators
Huashan Hospital
Principal Investigator: Li yi ming Huashan Hospital
  More Information

Responsible Party: Zhaoyun Zhang, Clinical Professor, Huashan Hospital Identifier: NCT01783717     History of Changes
Other Study ID Numbers: 2012-217
Study First Received: December 25, 2012
Last Updated: October 20, 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 21, 2017