PrediabetesNCT01860599
Effects of Aerobic Exercise in Patients With Pre-diabetes
A study testing Exercise and Without exercise in people with Prediabetes, run by Baystate Medical Center at 1 site in United States.
Trial summary
It is well known that diabetes and excessive or high blood sugars causes blood vessel and blood cell damage. It is also possible, then, that people with pre-diabetes may also start to have blood vessel and blood cell damage as the blood sugars rise from the normal range into the diabetic range. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Exercise and Without exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prediabetic
- Impaired fasting glucose (100-125mg/dl)
- Impaired glucose tolerance (2' post between 140-199mg/dl)
- HbA1C 5.7-6.4 mg/d (inclusive)
- Exercise Naive
- BMI between 20-39.9
Show all 9Show fewer
- Nutritional Counseling prior to participation with CDE/RD
- Willing to wear activity monitor
- Willing to keep a dietary log
Who cannot join
- Pace maker or other implanted device that might have interference with Tanita scale
- Any contraindication to moderate exercise
- Previous coronary disease or cerebrovascular event active or clinically significant coronary vascular disease, or peripheral vascular disease
- Diabetes
- Uncontrolled hypertension (SBP > 140 or DBP > 90 on 3 separate occasions) ACE's or ARB's
- Premature familial CAD (Father < 55years____ Mother <65years)
Show all 31Show fewer
- HDL < 40mg/dl
- Triglycerides >400mg/dl
- Any new lipid lowering medication started in the past 6 months
- Framingham Risk Score two or more
- Smoking
- Hypertension (B/P > 140/90 or on antihypertensives)
- HDL < 40mg/dl
- Age men >45years or women >55years
- Low hematocrit ( or hemoglobinopathies that may impair exercise tolerance) or abnormal CBC
- Uncontrolled hypo/hyperthyroidism
- Active smoking
- Liver disease ( alt or AST> 2.5's UNL)
- Moderate or Severe Kidney disease, current or history
- Pancreatitis, current or history
- Any medication started in the last 3 months
- Active non healing wounds
- Recent Surgery in the last 3 months
- Anti-inflammatory disease, current or history
- Regular use of anti-inflammatory drugs
- CA
- Alcoholism
- Women who are pregnant or intending to become pregnant
- Oral or Injectable antidiabetic medication
- Post menopausal women on hormone replacement
- Any steroid medication (oral, inhaled, injected or nasal)
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: The Effect of Controlled Aerobic Exercise on Endothelial Dysfunction and Vascular Reactivity in Patients With Pre-diabetes: A Crossover Pilot Study
It is well known that diabetes and excessive or high blood sugars causes blood vessel and blood cell damage. It is also possible, then, that people with pre-diabetes may also start to have blood vessel and blood cell damage as the blood sugars rise from the normal range into the diabetic range. In addition to looking at potential damage, the question is whether or not this damage improves with exercise. This study aims to look at blood vessel and blood cells in three different ways by 1) looking at how the blood vessel responds to "sheer force" (a blood pressure cuff pumped up and then released after a few minutes). This is done by ultrasound. 2) By looking at blood tests such as blood sugar, cholesterol, and inflammation and 3) By looking at certain blood cells in the lab, how long they live and the number of cells left after a certain number of days, and again, if this improves with exercise.
Read the detailed description
- To refine a non-invasive test for endothelial dysfunction. The investigators will examine the flow response to sheer-stress induced by the relief of pressure exerted with a blood pressure cuff on the brachial artery, measuring flow responses with Doppler. This is a measure of local nitric oxide production from endothelial cells which is known to be impaired in diabetics, normal in non-diabetics, but unknown in prediabetics.
- To measure in the same individuals indicators of glucose metabolism abnormalities including fasting blood glucose, HbA1C, insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR) and insulin levels.
- To measure Endothelial Progenitor Cell (EPC) count, viability, gene expression of key genes such as endothelial nitric oxide synthase (eNOS), von-Willebrand's Factor (vWF) and adhesion molecules such platelet-endothelial cell adhesion molecule-1 (PECAM-1 or CD31), cadherin such as Vascular-Endothelial cadherin (VE-cadherin)or CD (cell surface marker)-144, growth factors such as vascular-endothelial growth factor (VEGF)and Insulin like growth factor (IGF-1)in the EPCs from pre-diabetes subjects pre and post exercise.
- Correlate the glucose metabolism abnormalities with potential causative factors of endothelial dysfunction by studying EPC functions such as migration and tube formation and susceptibility to apoptosis in moderate hyperglycemia. Apoptosis assay will be done by Flow Cytometry analysis using Annexin V- Propidium-iodide dye.
- Subjects will be randomized to the intervention (structured exercise) or continuation of their usual life style (non-exercise, sedentary)group.
In both arms of the study, subjects will be encouraged to adhere to the standard dietary advice that all pre-diabetic patients receive as part of their standards of care, irrespective of design arm they will be in.
The investigators expect exercise to improve flow-mediated vasodilatation, EPC colony count and function, along with better key gene expressions noted by Real Time-qualitative polymerase chain reaction (PCR).
- Assess the effects of the intervention comparing them to the findings in each individual, in a paired manner.
- After a washout period, individuals will be crossed over to see whether the effects of the intervention are reversed and to demonstrate that the difference between controls and intervention subjects was due to the aerobic exercise intervention, and not due to random differences
- Conditions
- Prediabetes
- Being tested
- Exercise, Without exercise
- Keywords
- prediabetes, EPC's, vascular reactivity
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
150 minutes of moderate exercise per week
Without exerciseBehavioural
Pre-study activity level (i.e. no exercise)
| Study group | Role | What they receive |
|---|---|---|
| Prediabetes with exercise | Other | 150 minutes of moderate exercise per week Receives: Behavioral: Exercise |
| Prediabetes without exercise | Other | Pre-study activity level (i.e. no exercise) Receives: Behavioral: Without exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of Endothelial Function by studying number, function and gene expression of endothelial progenitor cells (identified as CD34+ cells)
- Number of viable CD34 +ve cells at Day-0 and viability assay. B. Colony Formation count assay at Day-5, pre and post exercise. C. We will test CD34+ cell migration, adhesion and tube formation properties. D. Gene expression in CD34+ cells of critical endothelial function and inflammatory genes will be measured: eNOS, vWF and PECAM1, VE-cadherin, VEGF-A, Superoxide dismutase (SOD)-1, 2 and 3, Catalase, Interleukin (IL)-6, Tumor Necrosis Factor (TNF alpha), P53, P21, PUMA, Bcl2 [Apoptosis genes] will also be noted
Measured: 16 weeks per patient
Secondary outcomes (1)
Measures of Vacular Reactivity
- Measure Brachial reactivity through shear-stress using flow mediated dilatation (FMD) B). Measure Arterial Stiffness measure pre and post exercise. C) Measure Carotid Intima Media Thickness will be measured at each time point
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMar 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabyasachi Sen, MD, Baystate Medical Center
- Investigators
- Sabyasachi Sen, MD, PhD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860599
- Sponsor's protocol ID
- IRB132171
- Status last verified
- Jul 2014
- First submitted
- 9 May 2013
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Controlled Aerobic Exercise on Endothelial Dysfunction and Vascular Reactivity in Patients With Pre-diabetes: A Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT01860599
- Acronym / sponsor ID
- IRB132171
- Conditions
- Prediabetes
- Keywords
- prediabetes, EPC's, vascular reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 May 2013 (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.
It is well known that diabetes and excessive or high blood sugars causes blood vessel and blood cell damage. It is also possible, then, that people with pre-diabetes may also start to have blood vessel and blood cell damage as the blood sugars rise from the normal range into the diabetic range. In addition to looking at potential damage, the question is whether or not this damage improves with exercise. This study aims to look at blood vessel and blood cells in three different ways by 1) looking at how the blood vessel responds to "sheer force" (a blood pressure cuff pumped up and then released after a few minutes). This is done by ultrasound. 2) By looking at blood tests such as blood sugar, cholesterol, and inflammation and 3) By looking at certain blood cells in the lab, how long they live and the number of cells left after a certain number of days, and again, if this improves with exercise.
Detailed description
- To refine a non-invasive test for endothelial dysfunction. The investigators will examine the flow response to sheer-stress induced by the relief of pressure exerted with a blood pressure cuff on the brachial artery, measuring flow responses with Doppler. This is a measure of local nitric oxide production from endothelial cells which is known to be impaired in diabetics, normal in non-diabetics, but unknown in prediabetics.
- To measure in the same individuals indicators of glucose metabolism abnormalities including fasting blood glucose, HbA1C, insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR) and insulin levels.
- To measure Endothelial Progenitor Cell (EPC) count, viability, gene expression of key genes such as endothelial nitric oxide synthase (eNOS), von-Willebrand's Factor (vWF) and adhesion molecules such platelet-endothelial cell adhesion molecule-1 (PECAM-1 or CD31), cadherin such as Vascular-Endothelial cadherin (VE-cadherin)or CD (cell surface marker)-144, growth factors such as vascular-endothelial growth factor (VEGF)and Insulin like growth factor (IGF-1)in the EPCs from pre-diabetes subjects pre and post exercise.
- Correlate the glucose metabolism abnormalities with potential causative factors of endothelial dysfunction by studying EPC functions such as migration and tube formation and susceptibility to apoptosis in moderate hyperglycemia. Apoptosis assay will be done by Flow Cytometry analysis using Annexin V- Propidium-iodide dye.
- Subjects will be randomized to the intervention (structured exercise) or continuation of their usual life style (non-exercise, sedentary)group.
In both arms of the study, subjects will be encouraged to adhere to the standard dietary advice that all pre-diabetic patients receive as part of their standards of care, irrespective of design arm they will be in.
The investigators expect exercise to improve flow-mediated vasodilatation, EPC colony count and function, along with better key gene expressions noted by Real Time-qualitative polymerase chain reaction (PCR).
- Assess the effects of the intervention comparing them to the findings in each individual, in a paired manner.
- After a washout period, individuals will be crossed over to see whether the effects of the intervention are reversed and to demonstrate that the difference between controls and intervention subjects was due to the aerobic exercise intervention, and not due to random differences
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prediabetes with exercise | Other | Behavioral: Exercise150 minutes of moderate exercise per week |
| Prediabetes without exercise | Other | Behavioral: Without exercisePre-study activity level (i.e. no exercise) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Prediabetic
- Exercise Naive
- BMI between 20-39.9
- Nutritional Counseling prior to participation with CDE/RD
- Willing to wear activity monitor
Key exclusion criteria (31 listed)
- Pace maker or other implanted device that might have interference with Tanita scale
- Any contraindication to moderate exercise
- Previous coronary disease or cerebrovascular event active or clinically significant coronary vascular disease, or peripheral vascular disease
- Diabetes
- Uncontrolled hypertension (SBP > 140 or DBP > 90 on 3 separate occasions) ACE's or ARB's
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 |
|---|---|---|
| Exercise150 minutes of moderate exercise per week | Behavioural | Prediabetes with exercise |
| Without exercisePre-study activity level (i.e. no exercise) | Behavioural | Prediabetes without exercise |
Primary outcome
Measures of Endothelial Function by studying number, function and gene expression of endothelial progenitor cells (identified as CD34+ cells)
Time frame: 16 weeks per patient
A. Number of viable CD34 +ve cells at Day-0 and viability assay. B. Colony Formation count assay at Day-5, pre and post exercise. C. We will test CD34+ cell migration, adhesion and tube formation properties. D. Gene expression in CD34+ cells of critical endothelial function and inflammatory genes will be measured: eNOS, vWF and PECAM1, VE-cadherin, VEGF-A, Superoxide dismutase (SOD)-1, 2 and 3, Catalase, Interleukin (IL)-6, Tumor Necrosis Factor (TNF alpha), P53, P21, PUMA, Bcl2 [Apoptosis genes] will also be noted
1 secondary outcome
Measures of Vacular Reactivity
Time frame: 16 weeks
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 Jul 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.
Sabyasachi Sen, MD, PhD principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Without exercise in people with Prediabetes, run by Baystate Medical Center 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 31 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 Jul 2014. 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.
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?
Measures of Endothelial Function by studying number, function and gene expression of endothelial progenitor cells (identified as CD34+ cells) (time frame: 16 weeks per patient). 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 17 Jul 2014.