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Deacylated Ghrelin and Beta Cell Function (UAG)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
David Dalessio, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01531283
First received: February 8, 2012
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
the Diabetic Process
 Drug: unacylated ghrelin
Drug: acyl ghrelin
Drug: combined acyl and desacyl ghrelin
Drug: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Impact of Unacylated Ghrelin on Beta-cell Function in Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • acute insulin release (AIRg) [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Insulin sensitivity [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: decaylated ghrelin
UAG (4.0 µg/kg/hr)
 Drug: unacylated ghrelin
IV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
Experimental: acyl ghrelin
AG (1.0 µg/kg/hr)
 Drug: acyl ghrelin
IV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
Experimental: combined acyl and desacyl ghrelin
the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr)
 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)
Placebo Comparator: saline
saline
 Drug: saline
IV, saline, one time, for the duration of the study visit(approximately 5 hours)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531283

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
David Dalessio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

No publications provided

Responsible Party: David Dalessio, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01531283     History of Changes
Other Study ID Numbers: 10-07-19-04, 1R03DK089090-01
Study First Received: February 8, 2012
Last Updated: November 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
unacylated ghrelin
beta cell function

ClinicalTrials.gov processed this record on May 22, 2013