Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341614
Status:
COMPLETED
Last Update Posted:
2007-08-16
First Post:
2006-06-19
Brief Title:
Exercise Training in Older Diabetic Women
Sponsor:
University of San Francisco
Organization:
University of San Francisco
Study Overview
Official Title:
The Effects of an Exercise and Diet Intervention on Cardiovascular Risk Factors in Postmenopausal Type 2 Diabetics
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 nondiabeticsFemale diabetics in particular have a higher mortality rate for coronary artery disease CAD than male diabeticsC-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 ie 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
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 ie 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 UCSFMt Zion Osteoporosis Center will be mailed a CHR approved recruitment letter that briefly describes the study purpose and eligibility criteria Only the individuals 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 MS The Naughton protocol will be used in which the grade is increased 35 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 gcm2
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 mgdl in the absence of hypohyperglycemic symptoms 6 In addition subjects will be monitored for 30 min post-exercise to verify that their BG is 70 mgdl 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 ie dietary recommendations low sodium diets blood glucose control
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 MS The Naughton protocol will be used in which the grade is increased 35 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 gcm2
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 mgdl in the absence of hypohyperglycemic symptoms 6 In addition subjects will be monitored for 30 min post-exercise to verify that their BG is 70 mgdl 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 ie dietary recommendations low sodium diets blood glucose control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None