Type 2 DiabetesExPRESSNCT00785005
What Makes Exercise Feel More Difficult to Women With and Without Type 2 Diabetes
An observational study of Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Given that sedentary behavior is associated with T2DM, the purpose of this study is to evaluate whether subjects with T2DM have a significant disincentive to performing exercise (due to greater perceived effort) . Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 2011
- Phase
- Observational
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty-five sedentary post-menopausal women with uncomplicated T2DM (of duration ≤ 10 years) between the ages of 50-70 and twenty-five sedentary non-diabetic post-menopausal women between the ages of 50-70 will be recruited.
Who may be able to join
- Sedentary women not participating in a regular exercise program (> one bout of exercise per week)
- If subject has diabetes, must be uncomplicated T2DM and < 25 years since T2DM diagnosis
- Ages of 50-70 years
- BMI of 25-35
- Subjects can only be taking the following oral hypoglycemic drugs: metformin, sulfonylureas or sitagliptin. Use of insulin or other oral hypoglycemic medications is not allowed.
- Persons with T2DM will be accepted for study only if they have total glycosylated hemoglobin levels (HbA1C) <8% (adequate control) on therapy.
Show all 10Show fewer
- Control subjects must have HbA1C < 5.5% and a fasting blood glucose of <100 mg/dl suggesting no significant insulin resistance.
- All women must be post-menopausal, documented by menstrual history and follicle stimulating hormone (FSH) level.
- Current smokers will be excluded since smoking can impair CV exercise performance but people who have quit smoking for at least 1 year will be accepted for study.
- Absence of comorbid conditions will be confirmed by history, physical examination and laboratory testing.
Who cannot join
- In general, people will be excluded with any condition which could limit exercise performance.
- Persons with clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded from further study as neuropathy may limit exercise performance.
- Persons with autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded as well, due to associated limitations of exercise performance.
- Persons will be excluded if they have evidence of heart disease by history (Prior heart attack or bypass surgery, heart failure, or significant valvular disease) or abnormal resting electrocardiogram (EKG) consistent with prior infarct or latent ischemia (unless cardiovascular stress imaging or catheterization shows they do not have coronary artery disease). We will also exclude subjects with left or right bundle branch block on resting EKG (precludes recognition of ischemic EKG changes with exercise) or abnormal exercise EKG (> 1 mm ST segment depression 80 msec out in the ST segment for 3 consecutive beats).
- Persons with angina or any other exercise-limiting cardiovascular, pulmonary or musculoskeletal symptoms will be excluded as well.
- Presence of systolic blood pressure >150 at rest or >250 with exercise or diastolic pressure >95 at rest or >105 with exercise are also grounds for exclusion.
Show all 10Show fewer
- Subjects with proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl, suggestive of renal disease will be excluded.
- Subjects with total cholesterol >220 mg/dl, low density lipoprotein > 130 mg/dl, or triglycerides > 250 mg/dl will be excluded given the potential insulin resistance and endothelial dysfunction associated with these cholesterol parameters.
- Subjects taking the following medications will be excluded: insulin, oral hypoglycemic agents other than those stated in inclusion criteria, estrogen-containing hormone replacement therapy including the "estring".
- Control subjects who have an immediate family member with type 2 diabetes will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Exercise-related Perceived Rate of Exertion at Steady-State Workloads (ExPRESS) in Type 2 Diabetes Mellitus
Given that sedentary behavior is associated with T2DM, the purpose of this study is to evaluate whether subjects with T2DM have a significant disincentive to performing exercise (due to greater perceived effort) . This study will prospectively compare the perceived exercise effort between T2DM and non-diabetic women while adjusting for potential confounders including baseline physical activity. This study will also assess whether perception of effort is associated with physiologic parameters related to exercise effort. Finally, we have 3 hypothesis-generating exploratory aims designed to screen for additional psychological and physiologic parameters that may increase perceived effort in those with T2DM.
Hypothesis 1: At the same absolute workload (e.g., 30 watts) and the same relative workloads, it is a greater effort for women with T2DM to exercise than for non-diabetic women.
Read more
Specific Aim 1: To determine differences in subjective perceived effort of bicycle exercise at low-to-moderate workloads in sedentary women with Type 2 Diabetes Mellitus (T2DM) vs. non-diabetic sedentary women.
Hypothesis 2: There will be a significant association between RPE and the physiologic measures related to work intensity (e.g., relative work intensity and tau2).
Specific Aim 2: In the same populations as SA1, to determine the strength of association during bicycle exercise between subjective perceived effort and physiologic measures related to work intensity.
Exploratory Aims:
Exploratory Aim 1: In the T2DM group described in SA1, to determine the strength of association during bicycle exercise between subjective effort and additional physiologic measures
Exploratory Aim 2: In the T2DM group described in SA1, to determine the strength of association during bicycle exercise between subjective effort and psychologic measures related to perception of effort.
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Exercise, Women, Research, Bike, Type, Control, Healthy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity, Limb-girdle muscular dystrophy, type 2C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Females with Type 2 Diabetes | |
| 2 | Females without Type 2 Diabetes |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startMay 2008
- 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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Huebschmann, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785005
- Sponsor's protocol ID
- 07-0849
- Acronym
- ExPRESS
- Status last verified
- Oct 2022
- First submitted
- 3 Nov 2008
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huebschmann AG, Kohrt WM, Herlache L, Wolfe P, Daugherty S, Reusch JE, Bauer TA, Regensteiner JG. Type 2 diabetes exaggerates exercise effort and impairs exercise performance in older women. BMJ Open Diabetes Res Care. 2015 Sep 30;3(1):e000124. doi: 10.1136/bmjdrc-2015-000124. eCollection 2015.
PubMed 26464803
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-related Perceived Rate of Exertion at Steady-State Workloads (ExPRESS) in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00785005
- Acronym / sponsor ID
- ExPRESS / 07-0849
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Exercise, Women, Research, Bike, Type, Control, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Nov 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.
Given that sedentary behavior is associated with T2DM, the purpose of this study is to evaluate whether subjects with T2DM have a significant disincentive to performing exercise (due to greater perceived effort) . This study will prospectively compare the perceived exercise effort between T2DM and non-diabetic women while adjusting for potential confounders including baseline physical activity. This study will also assess whether perception of effort is associated with physiologic parameters related to exercise effort. Finally, we have 3 hypothesis-generating exploratory aims designed to screen for additional psychological and physiologic parameters that may increase perceived effort in those with T2DM.
Hypothesis 1: At the same absolute workload (e.g., 30 watts) and the same relative workloads, it is a greater effort for women with T2DM to exercise than for non-diabetic women.
Specific Aim 1: To determine differences in subjective perceived effort of bicycle exercise at low-to-moderate workloads in sedentary women with Type 2 Diabetes Mellitus (T2DM) vs. non-diabetic sedentary women.
Hypothesis 2: There will be a significant association between RPE and the physiologic measures related to work intensity (e.g., relative work intensity and tau2).
Specific Aim 2: In the same populations as SA1, to determine the strength of association during bicycle exercise between subjective perceived effort and physiologic measures related to work intensity.
Exploratory Aims:
Exploratory Aim 1: In the T2DM group described in SA1, to determine the strength of association during bicycle exercise between subjective effort and additional physiologic measures
Exploratory Aim 2: In the T2DM group described in SA1, to determine the strength of association during bicycle exercise between subjective effort and psychologic measures related to perception of effort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Females with Type 2 Diabetes |
| 2 | – | –Females without Type 2 Diabetes |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-five sedentary post-menopausal women with uncomplicated T2DM (of duration ≤ 10 years) between the ages of 50-70 and twenty-five sedentary non-diabetic post-menopausal women between the ages of 50-70 will be recruited.
Key inclusion criteria (10 listed)
- Sedentary women not participating in a regular exercise program (> one bout of exercise per week)
- If subject has diabetes, must be uncomplicated T2DM and < 25 years since T2DM diagnosis
- Ages of 50-70 years
- BMI of 25-35
- Subjects can only be taking the following oral hypoglycemic drugs: metformin, sulfonylureas or sitagliptin. Use of insulin or other oral hypoglycemic medications is not allowed.
Key exclusion criteria (10 listed)
- In general, people will be excluded with any condition which could limit exercise performance.
- Persons with clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded from further study as neuropathy may limit exercise performance.
- Persons with autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded as well, due to associated limitations of exercise performance.
- Persons will be excluded if they have evidence of heart disease by history (Prior heart attack or bypass surgery, heart failure, or significant valvular disease) or abnormal resting electrocardiogram (EKG) consistent with prior infarct or latent ischemia (unless cardiovascular stress imaging or catheterization shows they do not have coronary artery disease). We will also exclude subjects with left or right bundle branch block on resting EKG (precludes recognition of ischemic EKG changes with exercise) or abnormal exercise EKG (> 1 mm ST segment depression 80 msec out in the ST segment for 3 consecutive beats).
- Persons with angina or any other exercise-limiting cardiovascular, pulmonary or musculoskeletal symptoms will be excluded as well.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Oct 2022.
- Derived from this study: PubMed 26464803Huebschmann AG, Kohrt WM, Herlache L, Wolfe P, Daugherty S, Reusch JE, Bauer TA, Regensteiner JG. Type 2 diabetes exaggerates exercise effort and impairs exercise performance in older women. BMJ Open Diabetes Res Care. 2015 Sep 30;3(1):e000124. doi: 10.1136/bmjdrc-2015-000124. eCollection 2015.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Amy Huebschmann, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Colorado, Denver 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 10 inclusion and 10 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 14 Oct 2022. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00785005, 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 14 Oct 2022.