Deacylated Ghrelin and Beta Cell Function (UAG)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
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

February 8, 2012
November 13, 2012
February 2011
April 2013   (final data collection date for primary outcome measure)
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.)
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.
Complete list of historical versions of study NCT01531283 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Not Provided
Not Provided
 
Deacylated Ghrelin and Beta Cell Function
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
the Diabetic Process
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01531283
10-07-19-04, 1R03DK089090-01
Yes
David Dalessio, University of Cincinnati
David Dalessio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
University of Cincinnati
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP