Metabolic SyndromePhase 1CANNCT00907127
Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome
A Phase 1 study testing Exercise and Diet (Metabolic Fitness Program) in people with Metabolic Syndrome, run by University of Michigan at 1 site in United States.
Trial summary
The study will test whether damage of the heart nerves appears in patients before they develop diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Exercise and Diet (Metabolic Fitness Program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have IGT or IFG and two other criteria of metabolic syndrome as defined by ATP III (IFG=fasting glucose ≥ 100 mg/dl (5.5 mmol/l))
- Definition of IGT/IFG: IGT/IFG will be defined based on the ADA diagnostic guidelines following an oral glucose tolerance test (OGTT) [2].
- Other Required Criteria (2 of the following):
- Waist circumference ≥ 102 cm (40 inches) in men and ≥ 88 cm (35 inches) in women, {for Asian-Americans: men ≥ 88 cm (35 inches), women ≥ 78 cm (31 inches)}
- Triglycerides ≥ 150 mg/dl (1.7 mmol/l) - patients on drug treatment with fibrates or nicotinic acid will be presumed to have triglycerides ≥ 150mg/dl and low HDL
- HDL cholesterol < 40 mg/dl (1.0 mmol/l) in men and < 50 mg/dl (1.3 mmol/l) in women,
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- Blood pressure ≥ 130/≥ 85 mmHg
- Age 18-65
- Women of childbearing potential must be using contraception to prevent pregnancy
Who cannot join
- Patients either pregnant or planning to become pregnant will be excluded
- Women of childbearing potential will have a urine pregnancy test as part of the screening visit
- Subjects who become pregnant during the study will undergo an exit visit and management of their IGT and Metabolic Syndrome will be returned to their primary care provider
- Subjects with pre-existing cardiovascular disease including:
- myocardial infarction
- congestive heart failure
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- known arrhythmias
- ventricular structural abnormalities and valvular disease
- peripheral vascular disease
- Subjects with hypoxemic lung or heart disease
- Subjects with established diabetes
- Laboratory evidence for a disease known to cause neuropathy within 3 months of screening will be an exclusion (those without known abnormality or those with a remote abnormality (> 3 months) will undergo the serologic screening)
- Significant neurological disease (e.g., Parkinson's disease, epilepsy, recent stroke)
- Subjects taking drugs which interfere with the uptake or metabolism of catecholamines
- Subjects with known history of chronic kidney disease or who have significant hepatic disease (AST, ALT > 3 times upper limit for normal) or a history of previous kidney, pancreas or cardiac transplantation.
- Subjects having taken systemic investigational drugs within the last 6 months
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
The study will test whether damage of the heart nerves appears in patients before they develop diabetes.
Read the detailed description
Patients who have mild abnormalities of blood sugar, high blood pressure, abnormal lipids and/or obesity can have a condition called metabolic syndrome. These patients are at high risk for diabetes and Cardiac Autonomic Neuropathy (CAN). Subjects with diagnosed metabolic syndrome will be expected to participate in the Metabolic Fitness Program which is a University of Michigan diet exercise program located in the Cardiology department at Domino Farms in Ann Arbor. Time required for this program and the study is 6 months. Clinic visits will involve Cardiac autonomic testing (CAN) procedures, PET scans and labs which will measure pre and post program intervention.
- Conditions
- Metabolic Syndrome
- Being tested
- Exercise and Diet (Metabolic Fitness Program)
- Keywords
- Metabolic, Syndrome, CAN
- Medical subject headings
- Metabolic Syndrome, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Diet (Metabolic Fitness Program)Behavioural
Also called Metabolic Fitness Program
6 month program of diet and exercise training and support.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet and Exercise | Active comparator | Mediterranean Diet and Exercise Receives: Behavioral: Exercise and Diet (Metabolic Fitness Program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac autonomic testing (CAN)
Measured: 6 months
Secondary outcomes (1)
PET Scan
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Rodica Pop-Busui, University of Michigan
- Investigators
- Rodica Pop-Busui, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907127
- Sponsor's protocol ID
- UM-5428
- Other IDs
- ADA
- Acronym
- CAN
- Status last verified
- Dec 2013
- First submitted
- 20 May 2009
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Mathew AV, Li L, Byun J, Guo Y, Michailidis G, Jaiswal M, Chen YE, Pop-Busui R, Pennathur S. Therapeutic Lifestyle Changes Improve HDL Function by Inhibiting Myeloperoxidase-Mediated Oxidation in Patients With Metabolic Syndrome. Diabetes Care. 2018 Nov;41(11):2431-2437. doi: 10.2337/dc18-0049. Epub 2018 Sep 10.
PubMed 30201848
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00907127
- Acronym / sponsor ID
- CAN / UM-5428
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic, Syndrome, CAN
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 May 2009 (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.
The study will test whether damage of the heart nerves appears in patients before they develop diabetes.
Detailed description
Patients who have mild abnormalities of blood sugar, high blood pressure, abnormal lipids and/or obesity can have a condition called metabolic syndrome. These patients are at high risk for diabetes and Cardiac Autonomic Neuropathy (CAN). Subjects with diagnosed metabolic syndrome will be expected to participate in the Metabolic Fitness Program which is a University of Michigan diet exercise program located in the Cardiology department at Domino Farms in Ann Arbor. Time required for this program and the study is 6 months. Clinic visits will involve Cardiac autonomic testing (CAN) procedures, PET scans and labs which will measure pre and post program intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet and Exercise | Active comparator | Behavioral: Exercise and Diet (Metabolic Fitness Program)Mediterranean Diet and Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must have IGT or IFG and two other criteria of metabolic syndrome as defined by ATP III (IFG=fasting glucose ≥ 100 mg/dl (5.5 mmol/l))
- Definition of IGT/IFG: IGT/IFG will be defined based on the ADA diagnostic guidelines following an oral glucose tolerance test (OGTT) [2].
- Other Required Criteria (2 of the following):
- Age 18-65
- Women of childbearing potential must be using contraception to prevent pregnancy
Key exclusion criteria (17 listed)
- Patients either pregnant or planning to become pregnant will be excluded
- Subjects with pre-existing cardiovascular disease including:
- Subjects with hypoxemic lung or heart disease
- Subjects with established diabetes
- Laboratory evidence for a disease known to cause neuropathy within 3 months of screening will be an exclusion (those without known abnormality or those with a remote abnormality (> 3 months) will undergo the serologic screening)
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 |
|---|---|---|
| Exercise and Diet (Metabolic Fitness Program)Also: Metabolic Fitness Program6 month program of diet and exercise training and support. | Behavioural | Mediterranean Diet and Exercise |
Primary outcome
Cardiac autonomic testing (CAN)
Time frame: 6 months
1 secondary outcome
PET Scan
Time frame: 6 month
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 17 Dec 2013.
- Derived from this study: PubMed 30201848Mathew AV, Li L, Byun J, Guo Y, Michailidis G, Jaiswal M, Chen YE, Pop-Busui R, Pennathur S. Therapeutic Lifestyle Changes Improve HDL Function by Inhibiting Myeloperoxidase-Mediated Oxidation in Patients With Metabolic Syndrome. Diabetes Care. 2018 Nov;41(11):2431-2437. doi: 10.2337/dc18-0049. Epub 2018 Sep 10.
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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.
Rodica Pop-Busui, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise and Diet (Metabolic Fitness Program) in people with Metabolic Syndrome, run by University of Michigan 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 9 inclusion and 17 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 17 Dec 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiac autonomic testing (CAN) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00907127, which also lists 1 linked publication.
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 17 Dec 2013.