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Trial record 5 of 6 for:    "Hypothalamic Obesity" | "Hormones"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01783717
Recruitment Status : Unknown
Verified October 2013 by Zhaoyun Zhang, Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : February 5, 2013
Last Update Posted : October 22, 2013
Information provided by (Responsible Party):
Zhaoyun Zhang, Huashan Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Hypothalamic Obesity Diabetes Mellitus Drug: Exenatide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Study Start Date : December 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01783717

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Contact: Zhang z yun 86-21-52888286

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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
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Principal Investigator: Li yi ming Huashan Hospital

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Responsible Party: Zhaoyun Zhang, Clinical Professor, Huashan Hospital Identifier: NCT01783717     History of Changes
Other Study ID Numbers: 2012-217
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents