Deacylated Ghrelin and Beta Cell Function

Not Applicable

• Conditions: the Diabetic Process
• Interventions: Drug: unacylated ghrelin; Drug: acyl ghrelin; Drug: combined acyl and desacyl ghrelin; Drug: saline

• Registration Number: NCT01531283
• Lead Sponsor: David Dalessio

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14
• Primary Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
decaylated ghrelin	unacylated ghrelin	UAG (4.0 µg/kg/hr)
acyl ghrelin	acyl ghrelin	AG (1.0 µg/kg/hr)
combined acyl and desacyl ghrelin	combined acyl and desacyl ghrelin	the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr)
saline	saline	saline

Primary Outcome Measures

Name	Time	Method
acute insulin release (AIRg)	one year	The primary outcome measure will be AIRg. This is calculated as the incremental insulin release,following IV glucose administration. (For the first ten minutes of the study visit.)

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity	one year	1. Insulin sensitivity is quantified as the insulin sensitivity index (SI) using Bergman's minimal model of glucose kinetics from the glucose and insulin results obtained from a FSIGT.
Disposition index	one year	2. The disposition index (DI) is a measure of β-cell function. It accounts for the modulating effect of insulin sensitivity on β-cell responses. It is calculated as the product of the SI and AIRg
glucose tolerance	one year	3. Glucose tolerance is measured by glucose disappearance constant. This is calculated as the slope of the natural log of glucose during the study visit, during a set time frame.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States