- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01531283
Deacylated Ghrelin and Beta Cell Function (UAG)
November 13, 2012 updated by: David Dalessio
Impact of Unacylated Ghrelin on Beta-cell Function in Humans
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- Ages between 18 and 50 years, inclusive.
- BMI between 18.5 and 29.9 kg/m2, inclusive
Exclusion Criteria:
- 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).
- A baseline resting systolic blood pressure of less than 100 mm Hg.
- 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.
- Anemia defined as hematocrit <33%.
- Use of medications that alter insulin sensitivity: niacin, glucocorticoids, metformin, thiazolidinediones, exenatide, or atypical anti-psychotics.
- Pregnancy or lactation.
- 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.
- 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.
- Females who are on progesterone-only contraception and those who have irregular menses.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: saline
|
IV, saline, one time, for the duration of the study visit(approximately 5 hours)
|
Experimental: decaylated ghrelin
UAG (4.0 µg/kg/hr)
|
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)
|
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)
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute insulin release (AIRg)
Time Frame: 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.)
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin sensitivity
Time Frame: 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.
|
one year
|
Disposition index
Time Frame: 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
|
one year
|
glucose tolerance
Time Frame: 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.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Anticipated)
April 1, 2013
Study Registration Dates
First Submitted
February 8, 2012
First Submitted That Met QC Criteria
February 9, 2012
First Posted (Estimate)
February 10, 2012
Study Record Updates
Last Update Posted (Estimate)
November 14, 2012
Last Update Submitted That Met QC Criteria
November 13, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10-07-19-04
- 1R03DK089090-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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