Cardiovascular DiseasesPhase 1NCT00341614
Exercise Training in Older Diabetic Women
A Phase 1 study testing 3-month Exercise Training and Diet Education in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by University of San Francisco at 1 site in United States.
Trial summary
Type 2 diabetics (non-insulin-dependent) are more than five times as likely to suffer an initial myocardial infarction (MI; heart attack) compared to nondiabetics.Female diabetics in particular, have a higher mortality rate for coronary artery disease (CAD) than male diabetics.C-reactive protein measurement in the… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
- What is being tested?
- 3-month Exercise Training and Diet Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to May 2007
- 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female 45-75 yrs old
- Type 2 diabetic for > 6 months
- "Reasonable" control of diabetes
- blood glucose within 100-250 mg/dl prior to exercise
- absence of hypoglycemic symptoms
- diabetes control verified by physician
Show all 11Show fewer
- cleared by physician to begin exercise program
- Postmenopausal > 6 months
- Sedentary
- Ability and willingness of patient to give written, informed consent
- Able and willing to participate in an exercise intervention
Who cannot join
- Diabetes not in control
- unable to maintain blood glucose within 100-250 mg/dl
- development of urinary ketone bodies (ketosis)
- symptoms of hypoglycemia before, during, and post-exercise
- no physician's approval to participate
- Male
Show all 26Show fewer
- Female <45 or >75 yr
- > 300 lb (weight limit for DXA table)
- On insulin
- Contraindications to Exercise Testing (ACSM, 2000)
- Ischemia
- Recent myocardial infarction
- Unstable angina
- Uncontrolled cardiac arrhythmias
- Severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus
- Acute myocarditis or pericarditis
- Dissecting aneurysm
- Acute infections
- Electrolyte abnormalities
- Severe hypertension (SBP > 200 mm Hg, DBP > 110 mm Hg at rest)
- Tachyarrhythmias or bradyarrhythmias
- Hypertrophic cardiomyopathy
- Neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise
- Not able to complete exercise testing (i.e must be ambulatory and without orthopedic limitations which would preclude maximal effort exercise)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: The Effects of an Exercise and Diet Intervention on Cardiovascular Risk Factors in Postmenopausal Type 2 Diabetics
Type 2 diabetics (non-insulin-dependent) are more than five times as likely to suffer an initial myocardial infarction (MI; heart attack) compared to nondiabetics.Female diabetics in particular, have a higher mortality rate for coronary artery disease (CAD) than male diabetics.C-reactive protein measurement in the clinical setting enhances the detection of individuals who are at high risk for cardiovascular disease (CVD), by providing additional predictive value.
We propose to study the effects of a supervised exercise and diet intervention on cardiovascular disease risk in postmenopausal diabetic women. We will recruit 35 postmenopausal, sedentary type 2 diabetics who will undergo a 3 month exercise and dietary intervention. They will exercise 3 times a week for 30 min in a supervised setting. Exercise mode will be aerobic and self-selected (i.e. treadmill, bike) at an intensity level of 50-85% VO2peak. Blood glucose will be monitored before and after exercise. The dietary intervention will consist of 6 meetings with a registered dietitian.
Read more
The study is designed to test the following hypotheses:
- Cardiovascular disease risk measures will be different following a 3-month exercise and diet intervention.
- H1: Blood markers for coronary artery disease risk, as measured by CRP, TC, LDL, TG, FG, fasting insulin, and HbA1c, will be different following a 3-month exercise and diet intervention.
- H2: Anthropometric measures of coronary artery disease risk, as measured by WHR, will be different following a 3-month exercise and diet intervention.
- H3: Resting blood pressure, as measured by SBP and DBP, will be different following a 3-month exercise and diet intervention.
- H4: Total body fat, as measured by DXA, will be different following a 3-month exercise and diet intervention.
- Health-related measures will be different following a 3-month exercise and diet intervention.
- H1: Cardiorespiratory fitness, as measured by maximal oxygen consumption (VO2max) will be different following a 3-month exercise and diet intervention.
- H2: Bone-mineral density, as measured by DXA, will be different following a 3-month exercise and diet intervention.
- H3: Dietary measures (total daily kcal, and daily fat kcal) will be different following a 3-month exercise and diet intervention.
Read the detailed description
- Recruitment: Participants who have signed up for the research recruitment mailing list at the UCSF/Mt. Zion Osteoporosis Center will be mailed a CHR approved recruitment letter that briefly describes the study purpose and eligibility criteria. Only the individual's name and address are on the mailing list; there is no medical information. Medical records are not accessed. Telephone screening will take place in the ESS Department at USF. A script will be followed.
- Pre and Post-Testing: Interested subject candidates will be scheduled to meet with Dr. Orri or Dr. Thompson at USF to provide written informed consent and complete a health history questionnaire (see appendix) to evaluate their CV risk. They will obtain written medical notification from their physician stating that they are in adequate diabetic control and cleared to begin an exercise program. Once selected, measurements of HT, WT, WHR, SBP, and DBP will take place in the ESS lab at USF.
- Blood draws: Subjects will arrive at the UCSF GCRC after a 12-hr fast. The blood variables obtained will include: CRP, TC, LDL-C, HDL-C, TG, FG, fasting insulin (HOMA calculated for marker of insulin resistance), and HbA1c. Approximately 2 tablespoons of blood will be drawn.
- Bone mineral density: BMD measurements (dual X-ray absorptiometry, DXA) will take place at the General Clinical Research Center at UCSF following the blood draw. A snack will be provided to the subjects prior to entering the DXA scanning area.
- Cardiorespiratory fitness: Maximal exercise testing will be using a treadmill protocol in the Exercise Physiology Laboratory at UCSF General Clinical Research Center. Tests will be conducted by Dr. Orri, Dr. Thompson, and Joanne Krasnoff, M.S. The Naughton protocol will be used in which the grade is increased 3.5% every 2 min, while the speed remains at 2 mph after the warmup. The subject continues until volitional exhaustion or the exercise technicians terminate test end as designated by the American College of Sports Medicine (ACSM).
All participants will have a 12-lead electrocardiogram (ECG) during the testing sessions to monitor for dysrhythmias or ischemia. Heart rate and blood pressure will be monitored every 2 minutes. Rating of perceived exertion (RPE) will be assessed every minute of the test. Maximal oxygen uptake (VO2max), as well as maximal levels of blood pressure, heart rate, respiratory exchange ratio (RER), and RPE will be recorded at the end of the test and used to determine the exercise training intensity. Expired gases will be collected throughout the test with CO2 and O2 and volume analyzed for calculation of oxygen uptake using a Quinton QMC computerized gas analysis system (Quinton Instruments, Bothell WA). All exercise technicians will be CPR and first-aid certified.
- Body composition and BMD: Per cent body fat (%BF) and BMD will determined using dual energy X-ray absorptiometry (DXA). All scans will be done on a GE-Lunar Prodigy (Madison, WI). Variables of interest from the DXA scan will be %BF, total fat mass, lean body mass (LBM), and bone mineral density in g/cm2.
- Exercise intervention: The 3-month exercise intervention will take place at the Millberry Union fitness center at UCSF, times per week for 30 min each session, accompanied by certified fitness professional who is trained to work with special populations. All standard emergency procedures will be followed by the trained UCSF staff.
- Exercise program design: Study participants will be required to complete 36 exercise sessions in the 12 week program. They will exercise a minimum of 3 times per week for 30 min, accompanied by certified fitness professional who is trained to work with special populations. Participants will wear a HR monitor and be instructed to maintain an intensity in the range of 50-85% VO2peak obtained through max testing. During the initial phase of training (first 4 weeks), participants who are unable to exercise continuously for 30 minutes will perform intermittent exercise bouts of 10 minutes followed by 5 min of rest. Mode of exercise will be self-selected and will involve large muscle groups, incorporating any combination of the following machines: treadmill, stationary cycle, elliptical, Stairmaster, or rowing ergometer.
- Blood glucose monitoring: Participants will be instructed to consume a snack 30-60 min before exercise. Prior to beginning each exercise session, all subjects will monitor their blood glucose to verify that it is between 100 and 250 mg/dl, in the absence of hypo/hyperglycemic symptoms (6). In addition, subjects will be monitored for 30 min post-exercise to verify that their BG is > 70 mg/dl. Juice and protein snacks (peanut butter \& crackers) will be available to the subjects in case of post-exercise hypoglycemia. The exercise supervisor will be aware of those subjects who are taking medications that promote insulin production and will carry a glucagon pen. Late-evening exercise sessions will be avoided in order to prevent nocturnal hypoglycemia.
- Dietary intervention: The subjects will receive six 30-min nutrition group counseling sessions with a dietitian. Sessions 1 and 6 will involve instruction on preparing 3-day dietary logs, while sessions 2-5 will consist of selected topics (i.e. dietary recommendations, low sodium diets, blood glucose control).
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
- Being tested
- 3-month Exercise Training and Diet Education
- Keywords
- Exercise, Diabetes Mellitus, Type 2, Postmenopause, Diet
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-month Exercise Training and Diet EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max at 3 months
Measured: 3 months
C-reactive protein at 3 months
Measured: 3 months
Blood lipids (total cholesterol, LDL, HDL, TC/HDL ratio, triglycerides) at 3 months
Measured: 3 months
Fasting glucose at 3 months
Measured: 3 months
Fasting insulin (insulin resistance) at 3 months
Measured: 3 months
HbA1C at 3 months
Measured: 3 months
Body fat % at 3 months
Measured: 3 months
Blood pressure (SBP, DBP) at 3 months
Measured: 3 months
Waist-hip ratio at 3 months
Measured: 3 months
Total kcal and fat kcal at 3 months
Measured: 3 months
Secondary outcomes (1)
Bone-mineral density at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startJun 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Investigators
- Deborah Sellmeyer, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341614
- Sponsor's protocol ID
- FDF-05-06
- Status last verified
- Aug 2007
- First submitted
- 19 Jun 2006
- Last updated
- 16 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Exercise and Diet Intervention on Cardiovascular Risk Factors in Postmenopausal Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT00341614
- Acronym / sponsor ID
- FDF-05-06
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
- Keywords
- Exercise, Diabetes Mellitus, Type 2, Postmenopause, Diet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of San FranciscoUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Jun 2006
- Study completion
- May 2007 (actual)
- First posted
- 21 Jun 2006 (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.
Type 2 diabetics (non-insulin-dependent) are more than five times as likely to suffer an initial myocardial infarction (MI; heart attack) compared to nondiabetics.Female diabetics in particular, have a higher mortality rate for coronary artery disease (CAD) than male diabetics.C-reactive protein measurement in the clinical setting enhances the detection of individuals who are at high risk for cardiovascular disease (CVD), by providing additional predictive value.
We propose to study the effects of a supervised exercise and diet intervention on cardiovascular disease risk in postmenopausal diabetic women. We will recruit 35 postmenopausal, sedentary type 2 diabetics who will undergo a 3 month exercise and dietary intervention. They will exercise 3 times a week for 30 min in a supervised setting. Exercise mode will be aerobic and self-selected (i.e. treadmill, bike) at an intensity level of 50-85% VO2peak. Blood glucose will be monitored before and after exercise. The dietary intervention will consist of 6 meetings with a registered dietitian.
The study is designed to test the following hypotheses:
- Cardiovascular disease risk measures will be different following a 3-month exercise and diet intervention.
- H1: Blood markers for coronary artery disease risk, as measured by CRP, TC, LDL, TG, FG, fasting insulin, and HbA1c, will be different following a 3-month exercise and diet intervention.
- H2: Anthropometric measures of coronary artery disease risk, as measured by WHR, will be different following a 3-month exercise and diet intervention.
- H3: Resting blood pressure, as measured by SBP and DBP, will be different following a 3-month exercise and diet intervention.
- H4: Total body fat, as measured by DXA, will be different following a 3-month exercise and diet intervention.
- Health-related measures will be different following a 3-month exercise and diet intervention.
- H1: Cardiorespiratory fitness, as measured by maximal oxygen consumption (VO2max) will be different following a 3-month exercise and diet intervention.
- H2: Bone-mineral density, as measured by DXA, will be different following a 3-month exercise and diet intervention.
- H3: Dietary measures (total daily kcal, and daily fat kcal) will be different following a 3-month exercise and diet intervention.
Detailed description
- Recruitment: Participants who have signed up for the research recruitment mailing list at the UCSF/Mt. Zion Osteoporosis Center will be mailed a CHR approved recruitment letter that briefly describes the study purpose and eligibility criteria. Only the individual's name and address are on the mailing list; there is no medical information. Medical records are not accessed. Telephone screening will take place in the ESS Department at USF. A script will be followed.
- Pre and Post-Testing: Interested subject candidates will be scheduled to meet with Dr. Orri or Dr. Thompson at USF to provide written informed consent and complete a health history questionnaire (see appendix) to evaluate their CV risk. They will obtain written medical notification from their physician stating that they are in adequate diabetic control and cleared to begin an exercise program. Once selected, measurements of HT, WT, WHR, SBP, and DBP will take place in the ESS lab at USF.
- Blood draws: Subjects will arrive at the UCSF GCRC after a 12-hr fast. The blood variables obtained will include: CRP, TC, LDL-C, HDL-C, TG, FG, fasting insulin (HOMA calculated for marker of insulin resistance), and HbA1c. Approximately 2 tablespoons of blood will be drawn.
- Bone mineral density: BMD measurements (dual X-ray absorptiometry, DXA) will take place at the General Clinical Research Center at UCSF following the blood draw. A snack will be provided to the subjects prior to entering the DXA scanning area.
- Cardiorespiratory fitness: Maximal exercise testing will be using a treadmill protocol in the Exercise Physiology Laboratory at UCSF General Clinical Research Center. Tests will be conducted by Dr. Orri, Dr. Thompson, and Joanne Krasnoff, M.S. The Naughton protocol will be used in which the grade is increased 3.5% every 2 min, while the speed remains at 2 mph after the warmup. The subject continues until volitional exhaustion or the exercise technicians terminate test end as designated by the American College of Sports Medicine (ACSM).
All participants will have a 12-lead electrocardiogram (ECG) during the testing sessions to monitor for dysrhythmias or ischemia. Heart rate and blood pressure will be monitored every 2 minutes. Rating of perceived exertion (RPE) will be assessed every minute of the test. Maximal oxygen uptake (VO2max), as well as maximal levels of blood pressure, heart rate, respiratory exchange ratio (RER), and RPE will be recorded at the end of the test and used to determine the exercise training intensity. Expired gases will be collected throughout the test with CO2 and O2 and volume analyzed for calculation of oxygen uptake using a Quinton QMC computerized gas analysis system (Quinton Instruments, Bothell WA). All exercise technicians will be CPR and first-aid certified.
- Body composition and BMD: Per cent body fat (%BF) and BMD will determined using dual energy X-ray absorptiometry (DXA). All scans will be done on a GE-Lunar Prodigy (Madison, WI). Variables of interest from the DXA scan will be %BF, total fat mass, lean body mass (LBM), and bone mineral density in g/cm2.
- Exercise intervention: The 3-month exercise intervention will take place at the Millberry Union fitness center at UCSF, times per week for 30 min each session, accompanied by certified fitness professional who is trained to work with special populations. All standard emergency procedures will be followed by the trained UCSF staff.
- Exercise program design: Study participants will be required to complete 36 exercise sessions in the 12 week program. They will exercise a minimum of 3 times per week for 30 min, accompanied by certified fitness professional who is trained to work with special populations. Participants will wear a HR monitor and be instructed to maintain an intensity in the range of 50-85% VO2peak obtained through max testing. During the initial phase of training (first 4 weeks), participants who are unable to exercise continuously for 30 minutes will perform intermittent exercise bouts of 10 minutes followed by 5 min of rest. Mode of exercise will be self-selected and will involve large muscle groups, incorporating any combination of the following machines: treadmill, stationary cycle, elliptical, Stairmaster, or rowing ergometer.
- Blood glucose monitoring: Participants will be instructed to consume a snack 30-60 min before exercise. Prior to beginning each exercise session, all subjects will monitor their blood glucose to verify that it is between 100 and 250 mg/dl, in the absence of hypo/hyperglycemic symptoms (6). In addition, subjects will be monitored for 30 min post-exercise to verify that their BG is > 70 mg/dl. Juice and protein snacks (peanut butter \& crackers) will be available to the subjects in case of post-exercise hypoglycemia. The exercise supervisor will be aware of those subjects who are taking medications that promote insulin production and will carry a glucagon pen. Late-evening exercise sessions will be avoided in order to prevent nocturnal hypoglycemia.
- Dietary intervention: The subjects will receive six 30-min nutrition group counseling sessions with a dietitian. Sessions 1 and 6 will involve instruction on preparing 3-day dietary logs, while sessions 2-5 will consist of selected topics (i.e. dietary recommendations, low sodium diets, blood glucose control).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female 45-75 yrs old
- Type 2 diabetic for > 6 months
- "Reasonable" control of diabetes
- Postmenopausal > 6 months
- Sedentary
Key exclusion criteria (26 listed)
- Diabetes not in control
- Male
- Female <45 or >75 yr
- > 300 lb (weight limit for DXA table)
- On insulin
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 |
|---|---|---|
| 3-month Exercise Training and Diet Education | Behavioural | – |
Primary outcome
VO2max at 3 months
Time frame: 3 months
C-reactive protein at 3 months
Time frame: 3 months
Blood lipids (total cholesterol, LDL, HDL, TC/HDL ratio, triglycerides) at 3 months
Time frame: 3 months
Fasting glucose at 3 months
Time frame: 3 months
Fasting insulin (insulin resistance) at 3 months
Time frame: 3 months
HbA1C at 3 months
Time frame: 3 months
Body fat % at 3 months
Time frame: 3 months
Blood pressure (SBP, DBP) at 3 months
Time frame: 3 months
Waist-hip ratio at 3 months
Time frame: 3 months
Total kcal and fat kcal at 3 months
Time frame: 3 months
1 secondary outcome
Bone-mineral density at 3 months
Time frame: 3 months
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 16 Aug 2007.
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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.
Deborah Sellmeyer, M.D. principal investigator
University of California, San Francisco
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 3-month Exercise Training and Diet Education in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by University of San Francisco 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 11 inclusion and 26 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 16 Aug 2007. 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?
VO2max at 3 months (time frame: 3 months). The study lists 10 primary outcomes in all. 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 16 Aug 2007.