the Diabetic ProcessUAGNCT01531283
Deacylated Ghrelin and Beta Cell Function
A study testing unacylated ghrelin, acyl ghrelin and combined acyl and desacyl ghrelin in people with the Diabetic Process, run by David Dalessio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- the Diabetic Process
- What is being tested?
- unacylated ghrelin, acyl ghrelin and combined acyl and desacyl ghrelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
- Conditions
- the Diabetic Process
- Being tested
- unacylated ghrelin, acyl ghrelin, combined acyl and desacyl ghrelin, saline
- Keywords
- unacylated ghrelin, beta cell function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unacylated ghrelinDrug
IV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
acyl ghrelinDrug
IV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
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)
salineDrug
IV, saline, one time, for the duration of the study visit(approximately 5 hours)
| Study group | Role | What they receive |
|---|---|---|
| decaylated ghrelin | Experimental | UAG (4.0 µg/kg/hr) Receives: Drug: unacylated ghrelin |
| acyl ghrelin | Experimental | AG (1.0 µg/kg/hr) Receives: Drug: acyl ghrelin |
| combined acyl and desacyl ghrelin | Experimental | the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr) Receives: Drug: combined acyl and desacyl ghrelin |
| saline | Placebo comparator | saline Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: one year
Secondary outcomes (3)
Insulin sensitivity
- 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.
Measured: one year
Disposition index
- 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
Measured: one year
glucose tolerance
- 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startFeb 2011
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Diabetic ProcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Dalessio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Dalessio, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531283
- Sponsor's protocol ID
- 10-07-19-04
- Other IDs
- 1R03DK089090-01
- Acronym
- UAG
- Status last verified
- Nov 2012
- First submitted
- 8 Feb 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Unacylated Ghrelin on Beta-cell Function in Humans
- ClinicalTrials.gov ID
- NCT01531283
- Acronym / sponsor ID
- UAG / 10-07-19-04
- Conditions
- the Diabetic Process
- Keywords
- unacylated ghrelin, beta cell function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- David DalessioUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (estimated)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| decaylated ghrelin | Experimental | Drug: unacylated ghrelinUAG (4.0 µg/kg/hr) |
| acyl ghrelin | Experimental | Drug: acyl ghrelinAG (1.0 µg/kg/hr) |
| combined acyl and desacyl ghrelin | Experimental | Drug: combined acyl and desacyl ghrelinthe combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr) |
| saline | Placebo comparator | Drug: salinesaline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unacylated ghrelinIV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours) | Drug | decaylated ghrelin |
| acyl ghrelinIV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours) | Drug | acyl ghrelin |
| combined acyl and desacyl ghrelinIV, 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 | combined acyl and desacyl ghrelin |
| salineIV, saline, one time, for the duration of the study visit(approximately 5 hours) | Drug | saline |
Primary outcome
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.)
3 secondary outcomes
Insulin sensitivity
Time frame: one year
Disposition index
Time frame: one year
glucose tolerance
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unacylated ghrelin, acyl ghrelin and combined acyl and desacyl ghrelin in people with the Diabetic Process, run by David Dalessio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute insulin release (AIRg) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.