An interventional study of Exenatide in Hypothalamic Obesity and Diabetes Mellitus, sponsored by Huashan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-10-22.
Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 10 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: Byetta
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
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
This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Huashan Hospital