NCT01531283

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

February 8, 2012

Last Update Submit

November 13, 2012

Conditions

the Diabetic Process

Keywords

unacylated ghrelinbeta cell function

Outcome Measures

Primary Outcomes (1)

  • acute insulin release (AIRg)

    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 Outcomes (3)

  • Insulin sensitivity

    one year

  • Disposition index

    one year

  • glucose tolerance

    one year

Study Arms (4)

decaylated ghrelin

EXPERIMENTAL

UAG (4.0 µg/kg/hr)

Drug: unacylated ghrelin

acyl ghrelin

EXPERIMENTAL

AG (1.0 µg/kg/hr)

Drug: acyl ghrelin

combined acyl and desacyl ghrelin

EXPERIMENTAL

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

Drug: combined acyl and desacyl ghrelin

saline

PLACEBO COMPARATOR

saline

Drug: saline

Interventions

unacylated ghrelinDRUG

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

decaylated ghrelin
acyl ghrelinDRUG

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

acyl ghrelin
combined acyl and desacyl ghrelinDRUG

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)

combined acyl and desacyl ghrelin
salineDRUG

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

saline

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

acyl-ghrelinghrelin, des-n-octanoylSodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 10, 2012

Study Start

February 1, 2011

Primary Completion

April 1, 2013

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

US(1)