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

Tracking Information
First Received Date ^ICMJE	February 8, 2012
Last Updated Date	November 13, 2012
Start Date ^ICMJE	February 2011
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 13, 2012)	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.)
Original Primary Outcome Measures ^ICMJE (submitted: February 9, 2012)	acute insulin release (AIRg) [ Time Frame: one year ] [ Designated as safety issue: No ] The primary outcome measure will be AIRg, calculated as the incremental insulin response above baseline from 2-10 minutes following IV glucose administration.
Change History	Complete list of historical versions of study NCT01531283 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 13, 2012)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: February 9, 2012)	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, which is calculated as the slope of the natural log of glucose from 10-19 min
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Deacylated Ghrelin and Beta Cell Function
Official Title ^ICMJE	Impact of Unacylated Ghrelin on Beta-cell Function in Humans
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject)
Condition ^ICMJE	the Diabetic Process
Intervention ^ICMJE	Drug: unacylated ghrelin IV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours) Drug: acyl ghrelin IV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours) 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) Drug: saline IV, saline, one time, for the duration of the study visit(approximately 5 hours)
Study Arm (s)	Experimental: decaylated ghrelin UAG (4.0 µg/kg/hr) Intervention: Drug: unacylated ghrelin Experimental: acyl ghrelin AG (1.0 µg/kg/hr) Intervention: Drug: acyl ghrelin Experimental: combined acyl and desacyl ghrelin the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr) Intervention: Drug: combined acyl and desacyl ghrelin Placebo Comparator: saline saline Intervention: Drug: saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	30
Completion Date	Not Provided
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01531283
Other Study ID Numbers ^ICMJE	10-07-19-04, 1R03DK089090-01
Has Data Monitoring Committee	Yes
Responsible Party	David Dalessio, University of Cincinnati
Study Sponsor ^ICMJE	David Dalessio
Collaborators ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators ^ICMJE	Not Provided
Information Provided By	University of Cincinnati
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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