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

This study is currently recruiting participants.
Verified February 2013 by Huashan Hospital
Sponsor:
Information provided by (Responsible Party):
Zhaoyun Zhang, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01783717
First received: December 25, 2012
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • Change in body weight frome baseline to end of the study. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Blood glucose level. [ Time Frame: 3 months. ] [ Designated as safety issue: No ]
  • Beta cell function. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Insulin sensitivity. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waistline [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Ratio of body fat [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • The amount of daily energy intake [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Resting energy expenditure (kcals per day) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Grade of metabolic equivalents (MET) scales [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Hipline. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • waistline/hipline ratio [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783717

Contacts
Contact: Zhang z yun 86-21-52888286

Locations
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
Investigators
Principal Investigator: Li yi ming Huashan Hospital
  More Information

No publications provided

Responsible Party: Zhaoyun Zhang, Clinical Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01783717     History of Changes
Other Study ID Numbers: 2012-217
Study First Received: December 25, 2012
Last Updated: February 1, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013