Deacylated Ghrelin and Beta Cell Function (UAG)

David Dalessio

Status: Unknown

Conditions: the Diabetic Process

Treatments: Drug: saline; Drug: acyl ghrelin; Drug: unacylated ghrelin; Drug: combined acyl and desacyl ghrelin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01531283

10-07-19-04

1R03DK089090-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 4 patient groups, including a placebo group

decaylated ghrelin

Experimental group

Description:

UAG (4.0 µg/kg/hr)

Treatment:

Drug: unacylated ghrelin

acyl ghrelin

Experimental group

Description:

AG (1.0 µg/kg/hr)

Treatment:

Drug: acyl ghrelin

combined acyl and desacyl ghrelin

Experimental group

Description:

the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr)

Treatment:

Drug: combined acyl and desacyl ghrelin

saline

Placebo Comparator group

Description:

saline

Treatment:

Drug: saline