Deacylated Ghrelin and Beta Cell Function

NCT ID: NCT01531283

Last Updated: 2012-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28

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.

Conditions

the Diabetic Process

Keywords

unacylated ghrelin; beta cell function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

decaylated ghrelin

UAG (4.0 µg/kg/hr)

Group Type: EXPERIMENTAL

unacylated ghrelin

Intervention Type: DRUG

IV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)

acyl ghrelin

AG (1.0 µg/kg/hr)

Group Type: EXPERIMENTAL

acyl ghrelin

Intervention Type: DRUG

IV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)

combined acyl and desacyl ghrelin

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

Group Type: EXPERIMENTAL

combined acyl and desacyl ghrelin

Intervention Type: DRUG

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)

saline

saline

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

IV, saline, one time, for the duration of the study visit(approximately 5 hours)

Interventions

unacylated ghrelin

IV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)

Intervention Type: DRUG

acyl ghrelin

IV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)

Intervention Type: DRUG

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)

Intervention Type: DRUG

saline

IV, saline, one time, for the duration of the study visit(approximately 5 hours)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

David Dalessio

OTHER

Sponsor Role: lead

Responsible Party

David Dalessio

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

1R03DK089090-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-07-19-04

Identifier Type: -

Identifier Source: org_study_id