Deacylated Ghrelin and Beta Cell Function



Status:Recruiting
Healthy:No
Age Range:Any
Updated:11/11/2012
Start Date:February 2011
Contact:Jenny Tong, MD, MPH
Email:jenny.tong@uc.edu
Phone:513-558-4446

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Impact of Unacylated Ghrelin on Beta-cell Function in Humans


Use of human unacylated ghrelin (UAG, also called des-octanoyl ghrelin) to study physiology
in healthy subjects. The proposed research is an investigator-initiated study funded by the
National Institutes of Health designed to examine the effect of physiologic levels of UAG on
the regulation of glucose homeostasis as well as beta cell function.


Inclusion Criteria:

1. Apparently healthy men and women. Only premenopausal women who are using an adequate
method of contraception at Screening and who agree to continue the contraception
during the study will be included. Male subjects do not need to use on birth
control.

2. Ages between 18 and 50 years, inclusive.

3. BMI between 18.5 and 29.9 kg/m2, inclusive

Exclusion Criteria:

1. History or clinical evidence of impaired fasting glucose or impaired glucose
tolerance or diabetes mellitus, myocardial infarction, history or symptoms of
congestive heart failure, history of cancer or anorexia nervosa, history or active
liver or renal disease (AST or ALT >2x upper limits of normal, calculated glomerular
filtration rate [GFR] <60).

2. A baseline resting systolic blood pressure of less than 100 mm Hg.

3. History of growth hormone deficiency or excess disorders (acromegaly, pituitary
gigantism, panhypopituitarism); history of adrenal insufficiency or Cushing's
disease/syndrome; history of neuroendocrine tumors.

4. Anemia defined as hematocrit <33%.

5. Use of medications that alter insulin sensitivity: niacin, glucocorticoids,
metformin, thiazolidinediones, exenatide, or atypical anti-psychotics.

6. Pregnancy or lactation.

7. BMI <18 kg/m2 or BMI >30 kg/m2; fasting plasma glucose >100 mg/dl and/or 2 hr plasma
glucose >140 mg/dl on a 75 g oral glucose tolerance test.

8. Electrocardiogram (ECG) abnormalities: specifically, myocardial ischemia, previous
myocardial ischemia, atrial fibrillation, second or third degree heart block and
complete right or left bundle branch block.

9. Females who are on progesterone-only contraception and those who have irregular
menses.
We found this trial at
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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