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

Primary Purpose

Hypothalamic Obesity, Diabetes Mellitus

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Exenatide

About this trial

This is an interventional treatment trial for Hypothalamic Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be between 18 and 55 years old;
Greater than 6 months post-treatment (including surgery, radiotherapy or chemotherapy) of craniopharyngioma or other diseases in the hypothalamic region;
BMI≧28kg/m2 and/or diabetes mellitus;
Greater than 3 months after adequate replacement therapy for hypothalamic-pituitary-adrenal (HPA) axis and hypothalamic-pituitary-thyroid (HPT) axis;
Sign informed consent document.

Exclusion Criteria:

Less than 6 months post surgery or radiotherapy or chemotherapy for craniopharyngioma or other diseases in the hypothalamic region;
Inadequate replacement for the HPA axis and HPT axis or undertaking adjustments of the kind or dose of the substitutive medicine;
Use of weight loss drugs or initiation of a weight loss program within past 3 months;
Use of GLP-1 agonists or analogues or dipeptidyl peptidase IV (DPP-IV) inhibitors within past 3 months;
History of bariatric surgery;
Diagnosed with simple obesity or diabetes mellitus prior to the hypothalamic disorders, and those diagnosed with type 1 diabetes mellitus;
With end-stage-renal diseases or history of kidney transplant or complicated with acute/chronic kidney failure (GFR≦30ml/min);
History of inflammatory bowel diseases or gastroparesis or other gastric mortility problems;
History of pancreatitis or chronic cholecystitis;
History of allergic reaction to exenatide or other medication components;
Undertaking warfarin;
Pregnant or lactating women;
Are participating in, or have participated in other drug clinical trials within past 3 months.

Sites / Locations

Department of Endocrinology and MetabolismRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exenatide

Arm Description

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

Outcomes

Primary Outcome Measures

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

BMI

HbA1c

Blood glucose level.

Beta cell function.

Insulin sensitivity.

Secondary Outcome Measures

Waistline

Ratio of body fat

The amount of daily energy intake

Resting energy expenditure (kcals per day)

Grade of metabolic equivalents (MET) scales

Hipline.

waistline/hipline ratio

Full Information

NCT ID

NCT01783717

First Posted

December 25, 2012

Last Updated

October 20, 2013

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01783717

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

January 2015 (Anticipated)

Study Completion Date

July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypothalamic Obesity, Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exenatide

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Exenatide

Other Intervention Name(s)

Byetta

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Title

BMI

Time Frame

baseline and 3 months

Title

HbA1c

Time Frame

baseline and 3 months

Title

Blood glucose level.

Time Frame

3 months.

Title

Beta cell function.

Time Frame

baseline and 3 months

Title

Insulin sensitivity.

Time Frame

baseline and 3 months

Secondary Outcome Measure Information:

Title

Waistline

Time Frame

baseline and 3 months

Title

Ratio of body fat

Time Frame

baseline and 3 months

Title

The amount of daily energy intake

Time Frame

baseline and 3 months

Title

Resting energy expenditure (kcals per day)

Time Frame

baseline and 3 months

Title

Grade of metabolic equivalents (MET) scales

Time Frame

baseline and 3 months

Title

Hipline.

Time Frame

baseline and 3 months

Title

waistline/hipline ratio

Time Frame

baseline and 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be between 18 and 55 years old; Greater than 6 months post-treatment (including surgery, radiotherapy or chemotherapy) of craniopharyngioma or other diseases in the hypothalamic region; BMI≧28kg/m2 and/or diabetes mellitus; Greater than 3 months after adequate replacement therapy for hypothalamic-pituitary-adrenal (HPA) axis and hypothalamic-pituitary-thyroid (HPT) axis; Sign informed consent document. Exclusion Criteria: Less than 6 months post surgery or radiotherapy or chemotherapy for craniopharyngioma or other diseases in the hypothalamic region; Inadequate replacement for the HPA axis and HPT axis or undertaking adjustments of the kind or dose of the substitutive medicine; Use of weight loss drugs or initiation of a weight loss program within past 3 months; Use of GLP-1 agonists or analogues or dipeptidyl peptidase IV (DPP-IV) inhibitors within past 3 months; History of bariatric surgery; Diagnosed with simple obesity or diabetes mellitus prior to the hypothalamic disorders, and those diagnosed with type 1 diabetes mellitus; With end-stage-renal diseases or history of kidney transplant or complicated with acute/chronic kidney failure (GFR≦30ml/min); History of inflammatory bowel diseases or gastroparesis or other gastric mortility problems; History of pancreatitis or chronic cholecystitis; History of allergic reaction to exenatide or other medication components; Undertaking warfarin; Pregnant or lactating women; Are participating in, or have participated in other drug clinical trials within past 3 months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhang z yun

Phone

86-21-52888286

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li yi ming

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Endocrinology and Metabolism

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ye h ying

Phone

86-21-52887027

First Name & Middle Initial & Last Name & Degree

Zhang z yun

12. IPD Sharing Statement

Learn more about this trial

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

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