DiabetesNCT00780195
Metabolic Adaptations to Diabetes in African Americans
A study testing glucose clamp in people with Diabetes, run by Vanderbilt University.
Trial summary
We do not know why diabetic patients cannot protect themselves against low blood sugar. Therefore, in this study, we will perform a comprehensive assessment of the body's response to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve signals. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- glucose clamp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jul 1998to Dec 2010
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged 18-40 yrs with no family history of diabetes mellitus.
- All prospective volunteers will have routine blood tests to screen for biochemical, hormonal and hematological abnormalities.
- Female volunteers will also undergo an HCG urine pregnancy test.
Who cannot join
- Prior or current history of poor health
- Abnormal results following blood and physical examination
- Pregnancy
About this study
Official title: Metabolic Adaptations to Diabetes
We do not know why diabetic patients cannot protect themselves against low blood sugar. Therefore, in this study, we will perform a comprehensive assessment of the body's response to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve signals.
Read the detailed description
Morning and afternoon hypoglycemic episodes of 70, 60, or 50 mg/dl produce increased blunting of subsequent counterregulation dependent upon the depth of preceding hypoglycemia. We wanted to test this hypothesis in healthy African American individuals to determine if there is a difference in their responses to varying depths of hypoglycemia.
- Conditions
- Diabetes
- Being tested
- glucose clamp
- Keywords
- hypoglycemia, African Americans
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose clampProcedure or surgery
2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)
glucose clampProcedure or surgery
2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)
glucose clampProcedure or surgery
2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)
glucose clampProcedure or surgery
2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single 2 hour hyperinsulinemic euglycemic clamp study at ~90 mg/dl. Receives: Procedure: glucose clamp |
| 2 | Experimental | Single 2 hour hyperinsulinemic hypoglycemic clamp study at ~70 mg/dl. Receives: Procedure: glucose clamp |
| 3 | Experimental | Single 2 hour hyperinsulinemic hypoglycemic clamp at ~60 mg/dl. Receives: Procedure: glucose clamp |
| 4 | Experimental | Single, 2 hour hyperinsulinemic hypoglycemic clamp at ~50 mg/dl. Receives: Procedure: glucose clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
catecholamines
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startJul 1998
- Primary completionNov 2000
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Davis, Vanderbilt University
- Investigators
- Stephen N. Davis, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780195
- Sponsor's protocol ID
- IRB # 8177
- Status last verified
- Dec 2014
- First submitted
- 24 Oct 2008
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Adaptations to Diabetes
- ClinicalTrials.gov ID
- NCT00780195
- Acronym / sponsor ID
- IRB # 8177
- Conditions
- Diabetes
- Keywords
- hypoglycemia, African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 1998
- Primary completion
- Nov 2000 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Oct 2008 (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.
We do not know why diabetic patients cannot protect themselves against low blood sugar. Therefore, in this study, we will perform a comprehensive assessment of the body's response to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve signals.
Detailed description
Morning and afternoon hypoglycemic episodes of 70, 60, or 50 mg/dl produce increased blunting of subsequent counterregulation dependent upon the depth of preceding hypoglycemia. We wanted to test this hypothesis in healthy African American individuals to determine if there is a difference in their responses to varying depths of hypoglycemia.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: glucose clampSingle 2 hour hyperinsulinemic euglycemic clamp study at ~90 mg/dl. |
| 2 | Experimental | Procedure: glucose clampSingle 2 hour hyperinsulinemic hypoglycemic clamp study at ~70 mg/dl. |
| 3 | Experimental | Procedure: glucose clampSingle 2 hour hyperinsulinemic hypoglycemic clamp at ~60 mg/dl. |
| 4 | Experimental | Procedure: glucose clampSingle, 2 hour hyperinsulinemic hypoglycemic clamp at ~50 mg/dl. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females aged 18-40 yrs with no family history of diabetes mellitus.
- All prospective volunteers will have routine blood tests to screen for biochemical, hormonal and hematological abnormalities.
- Female volunteers will also undergo an HCG urine pregnancy test.
Key exclusion criteria (3 listed)
- Prior or current history of poor health
- Abnormal results following blood and physical examination
- Pregnancy
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 |
|---|---|---|
| glucose clamp2 hour hyperinsulinemic euglycemic clamp (90 mg/dl) | Procedure or surgery | 1 |
| glucose clamp2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl) | Procedure or surgery | 2 |
| glucose clamp2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl) | Procedure or surgery | 3 |
| glucose clamp2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl) | Procedure or surgery | 4 |
Primary outcome
catecholamines
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Stephen N. Davis, MD principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
A study testing glucose clamp in people with Diabetes, run by Vanderbilt University.
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 3 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: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
catecholamines (time frame: 2 hours). 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 11 Dec 2014.