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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight frome baseline to end of the study. | 3 months | |
| BMI | baseline and 3 months | |
| HbA1c | baseline and 3 months | |
| Blood glucose level. | 3 months. | |
| Beta cell function. | baseline and 3 months | |
| Insulin sensitivity. | baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Waistline | baseline and 3 months | |
| Ratio of body fat | baseline and 3 months | |
| The amount of daily energy intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang z yun | Contact | 86-21-52888286 |
| Name | Affiliation | Role |
|---|---|---|
| Li yi ming | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Metabolism | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D050035 | Sexual Infantilism |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| baseline and 3 months |
| Resting energy expenditure (kcals per day) | baseline and 3 months |
| Grade of metabolic equivalents (MET) scales | baseline and 3 months |
| Hipline. | baseline and 3 months |
| waistline/hipline ratio | baseline and 3 months |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007006 | Hypogonadism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |