This trial is active, not recruiting.

Condition the diabetic process
Treatments unacylated ghrelin, acyl ghrelin, combined acyl and desacyl ghrelin, saline
Sponsor David Dalessio
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date February 2011
End date April 2013
Trial size 30 participants
Trial identifier NCT01531283, 10-07-19-04, 1R03DK089090-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
UAG (4.0 µg/kg/hr)
unacylated ghrelin
IV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
AG (1.0 µg/kg/hr)
acyl ghrelin
IV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr)
combined acyl and desacyl ghrelin
IV, the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr), one time, for the duration of the study visit (approximately 5 hours)
(Placebo Comparator)
IV, saline, one time, for the duration of the study visit(approximately 5 hours)

Primary Outcomes

acute insulin release (AIRg)
time frame: one year

Secondary Outcomes

Insulin sensitivity
time frame: one year
Disposition index
time frame: one year
glucose tolerance
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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.

Additional Information

Official title Impact of Unacylated Ghrelin on Beta-cell Function in Humans
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by University of Cincinnati.