Pre-DiabetesSTRRIDE-PDNCT00962962
Exercise Dose-Response Effects in Prediabetes
A study testing Aerobic Exercise and Exercise and Diet in people with Pre-Diabetes, run by Duke University at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effects of different amounts and intensities of aerobic exercise training programs, with and without weight loss, in people who are at risk for diabetes. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Pre-Diabetes
- What is being tested?
- Aerobic Exercise and Exercise and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 45-75 years
- Moderately Overweight determined by Body Mass Index: 25.0 - 35.4
- Fasting plasma glucose: > 95 - < 126 mg/dL until 2/15/2012 when lower limit was adjusted to > 100 mg/dL
- o Readings from two separate days, both being > 95 (> 100 after 2/15/2012)and one of the two being < 126
- Low density (LDL) cholesterol: < 190 mg/dL
- Triglycerides: < 600 mg/dL
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- Resting blood pressure: < 160/90 mmHg
- Inactive: Exercise < one day/week; Peak oxygen consumption: > 18.0 - < 40.0 ml/kg/min until 2/15/2012 when lower limit was adjusted to 12.0 ml/kg/min
- Medications: Stable use of all medications for > three months
Who cannot join
- Smoker: Tobacco use within the last 12 months
- Dieting or intending to diet
- Use of potential confounding medications, e.g. Niacin containing drugs
- History of diabetes, heart disease or taking medication for those conditions
- History of hypertension (high blood pressure) not controlled with medication
- Pregnant or intending to become pregnant
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- Unwillingness to undergo a three month control/run-in period, be randomized to any one of four intervention groups, submit to thigh muscle biopsies and all other study testing or continuously participate in a randomly assigned exercise training or lifestyle intervention program for six months
- Orthopedic limitations, musculoskeletal disease and/or injury
- Allergic to xylocaine (anesthetic or numbing medicine)
- Inability to give blood continuously through a catheter (please notify the study nurse of any difficulty you have experienced in the past when having your blood drawn; the study nurse will determine whether you are excluded for this reason)
- Unwillingness to exercise at least twice per week at the Duke Center for Living Health and Fitness Center during research study staff supervised times
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center For Living
Durham, North Carolina, 27710
About this study
Official title: Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms
The purpose of the study is to evaluate the effects of different amounts and intensities of aerobic exercise training programs, with and without weight loss, in people who are at risk for diabetes. An additional purpose of the study is to evaluate the factors in the blood and in exercising muscles that contribute to the improvement in those risk factors. This information will be used to improve exercise training guidelines for improving cardiovascular and metabolic health in people with abnormal fasting glucose, also known as prediabetes.
Read the detailed description
729 subjects were consented, 288 participants were randomized.
- Conditions
- Pre-Diabetes
- Being tested
- Aerobic Exercise, Exercise and Diet
- Keywords
- Abnormal fasting glucose
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,000 calories per week equaling approximately 10 miles per week OR 2.5-3.5 hours per week
Aerobic ExerciseBehavioural
Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 4-6 hours per week
Aerobic ExerciseBehavioural
Aerobic exercise at 75% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 2-3 hours per week
Exercise and DietBehavioural
- Exercise - 150 minutes per week (30 minutes / 5 days per week) of aerobic exercise at 50% peak oxygen use/consumption equaling approximately 10 miles per week
- Diet - The Clinical Lifestyle Intervention sessions will provide training on needed skills (e.g., calorie counting, portion size estimation) as well as motivation and support in a group counseling setting designed to achieve a weight loss goal of 5 to 7% of baseline body weight.
| Study group | Role | What they receive |
|---|---|---|
| Low-Amount/Moderate Intensity Exercise | Other | Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,000 calories per week equaling approximately 10 miles per week OR 2.5-3.5 hours per week Receives: Behavioral: Aerobic Exercise |
| High-Amount/Moderate-Intensity Exercise | Other | Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 4-6 hours per week Receives: Behavioral: Aerobic Exercise |
| High-Amount/Vigorous-Intensity Exercise | Other | Aerobic exercise at 75% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 2-3 hours per week Receives: Behavioral: Aerobic Exercise |
| Low-Amount/Moderate-Intensity Exercise + Diet | Other | * Exercise - 150 minutes per week (30 minutes / 5 days per week) of aerobic exercise at 50% peak oxygen use/consumption equaling approximately 10 miles per week
* Diet - The CLI sessions will provide training on needed skills (e.g., calorie counting, portion size estimation) as well as motivation and support in a group counseling setting designed to achieve a weight loss goal of 5 to 7% of baseline body weight. Receives: Behavioral: Exercise and Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma Glucose
Measured: 3 month control and 6 months intervention
Secondary outcomes (1)
Measures of Glucose control
Measured: 3 month control and 6 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pre-DiabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William E Kraus, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962962
- Sponsor's protocol ID
- Pro00012628
- Other IDs
- R01DK081559
- Acronym
- STRRIDE-PD
- Status last verified
- Sep 2013
- First submitted
- 19 Aug 2009
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jiang R, Collins KA, Huffman KM, Hauser ER, Hubal MJ, Johnson JL, Williams RB, Siegler IC, Kraus WE. Genome-Wide Genetic Analysis of Dropout in a Controlled Exercise Intervention in Sedentary Adults With Overweight or Obesity and Cardiometabolic Disease. Ann Behav Med. 2024 Apr 11;58(5):363-374. doi: 10.1093/abm/kaae011.
PubMed 38489667Bennett WC, Collins KA, Johnson JL, Slentz CA, Willis LH, Bales CW, Huffman KM, Kraus WE. Effects of exercise amount and intensity versus a combined exercise and lifestyle intervention on metabolic syndrome in adults with prediabetes: a STRRIDE-PD randomized trial. Front Physiol. 2023 Jul 14;14:1199763. doi: 10.3389/fphys.2023.1199763. eCollection 2023.
PubMed 37520827Sarzynski MA, Ruiz-Ramie JJ, Barber JL, Slentz CA, Apolzan JW, McGarrah RW, Harris MN, Church TS, Borja MS, He Y, Oda MN, Martin CK, Kraus WE, Rohatgi A. Effects of Increasing Exercise Intensity and Dose on Multiple Measures of HDL (High-Density Lipoprotein) Function. Arterioscler Thromb Vasc Biol. 2018 Apr;38(4):943-952. doi: 10.1161/ATVBAHA.117.310307. Epub 2018 Feb 8.
PubMed 29437573Bartlett DB, Slentz CA, Connelly MA, Piner LW, Willis LH, Bateman LA, Granville EO, Bales CW, Huffman KM, Kraus WE. Association of the Composite Inflammatory Biomarker GlycA, with Exercise-Induced Changes in Body Habitus in Men and Women with Prediabetes. Oxid Med Cell Longev. 2017;2017:5608287. doi: 10.1155/2017/5608287. Epub 2017 May 31.
PubMed 28642810Slentz CA, Bateman LA, Willis LH, Granville EO, Piner LW, Samsa GP, Setji TL, Muehlbauer MJ, Huffman KM, Bales CW, Kraus WE. Effects of exercise training alone vs a combined exercise and nutritional lifestyle intervention on glucose homeostasis in prediabetic individuals: a randomised controlled trial. Diabetologia. 2016 Oct;59(10):2088-98. doi: 10.1007/s00125-016-4051-z. Epub 2016 Jul 15.
PubMed 27421729
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms
- ClinicalTrials.gov ID
- NCT00962962
- Acronym / sponsor ID
- STRRIDE-PD / Pro00012628
- Conditions
- Pre-Diabetes
- Keywords
- Abnormal fasting glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Aug 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 purpose of the study is to evaluate the effects of different amounts and intensities of aerobic exercise training programs, with and without weight loss, in people who are at risk for diabetes. An additional purpose of the study is to evaluate the factors in the blood and in exercising muscles that contribute to the improvement in those risk factors. This information will be used to improve exercise training guidelines for improving cardiovascular and metabolic health in people with abnormal fasting glucose, also known as prediabetes.
Detailed description
729 subjects were consented, 288 participants were randomized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-Amount/Moderate Intensity Exercise | Other | Behavioral: Aerobic ExerciseAerobic exercise at 50% peak oxygen use/consumption expending approximately 1,000 calories per week equaling approximately 10 miles per week OR 2.5-3.5 hours per week |
| High-Amount/Moderate-Intensity Exercise | Other | Behavioral: Aerobic ExerciseAerobic exercise at 50% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 4-6 hours per week |
| High-Amount/Vigorous-Intensity Exercise | Other | Behavioral: Aerobic ExerciseAerobic exercise at 75% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 2-3 hours per week |
| Low-Amount/Moderate-Intensity Exercise + Diet | Other | Behavioral: Exercise and Diet* Exercise - 150 minutes per week (30 minutes / 5 days per week) of aerobic exercise at 50% peak oxygen use/consumption equaling approximately 10 miles per week * Diet - The CLI sessions will provide training on needed skills (e.g., calorie counting, portion size estimation) as well as motivation and support in a group counseling setting designed to achieve a weight loss goal of 5 to 7% of baseline body weight. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 45-75 years
- Moderately Overweight determined by Body Mass Index: 25.0 - 35.4
- Fasting plasma glucose: > 95 - < 126 mg/dL until 2/15/2012 when lower limit was adjusted to > 100 mg/dL
- o Readings from two separate days, both being > 95 (> 100 after 2/15/2012)and one of the two being < 126
- Low density (LDL) cholesterol: < 190 mg/dL
Key exclusion criteria (11 listed)
- Smoker: Tobacco use within the last 12 months
- Dieting or intending to diet
- Use of potential confounding medications, e.g. Niacin containing drugs
- History of diabetes, heart disease or taking medication for those conditions
- History of hypertension (high blood pressure) not controlled with medication
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 |
|---|---|---|
| Aerobic ExerciseAerobic exercise at 50% peak oxygen use/consumption expending approximately 1,000 calories per week equaling approximately 10 miles per week OR 2.5-3.5 hours per week | Behavioural | Low-Amount/Moderate Intensity Exercise |
| Aerobic ExerciseAerobic exercise at 50% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 4-6 hours per week | Behavioural | High-Amount/Moderate-Intensity Exercise |
| Aerobic ExerciseAerobic exercise at 75% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 2-3 hours per week | Behavioural | High-Amount/Vigorous-Intensity Exercise |
| Exercise and Diet* Exercise - 150 minutes per week (30 minutes / 5 days per week) of aerobic exercise at 50% peak oxygen use/consumption equaling approximately 10 miles per week * Diet - The Clinical Lifestyle Intervention sessions will provide training on needed skills (e.g., calorie counting, portion size estimation) as well as motivation and support in a group counseling setting designed to achieve a weight loss goal of 5 to 7% of baseline body weight. | Behavioural | Low-Amount/Moderate-Intensity Exercise + Diet |
Primary outcome
Fasting Plasma Glucose
Time frame: 3 month control and 6 months intervention
1 secondary outcome
Measures of Glucose control
Time frame: 3 month control and 6 month intervention
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 15 Jul 2014.
- Derived from this study: PubMed 38489667Jiang R, Collins KA, Huffman KM, Hauser ER, Hubal MJ, Johnson JL, Williams RB, Siegler IC, Kraus WE. Genome-Wide Genetic Analysis of Dropout in a Controlled Exercise Intervention in Sedentary Adults With Overweight or Obesity and Cardiometabolic Disease. Ann Behav Med. 2024 Apr 11;58(5):363-374. doi: 10.1093/abm/kaae011.
- Derived from this study: PubMed 37520827Bennett WC, Collins KA, Johnson JL, Slentz CA, Willis LH, Bales CW, Huffman KM, Kraus WE. Effects of exercise amount and intensity versus a combined exercise and lifestyle intervention on metabolic syndrome in adults with prediabetes: a STRRIDE-PD randomized trial. Front Physiol. 2023 Jul 14;14:1199763. doi: 10.3389/fphys.2023.1199763. eCollection 2023.
- Derived from this study: PubMed 29437573Sarzynski MA, Ruiz-Ramie JJ, Barber JL, Slentz CA, Apolzan JW, McGarrah RW, Harris MN, Church TS, Borja MS, He Y, Oda MN, Martin CK, Kraus WE, Rohatgi A. Effects of Increasing Exercise Intensity and Dose on Multiple Measures of HDL (High-Density Lipoprotein) Function. Arterioscler Thromb Vasc Biol. 2018 Apr;38(4):943-952. doi: 10.1161/ATVBAHA.117.310307. Epub 2018 Feb 8.
- Derived from this study: PubMed 28642810Bartlett DB, Slentz CA, Connelly MA, Piner LW, Willis LH, Bateman LA, Granville EO, Bales CW, Huffman KM, Kraus WE. Association of the Composite Inflammatory Biomarker GlycA, with Exercise-Induced Changes in Body Habitus in Men and Women with Prediabetes. Oxid Med Cell Longev. 2017;2017:5608287. doi: 10.1155/2017/5608287. Epub 2017 May 31.
- Derived from this study: PubMed 27421729Slentz CA, Bateman LA, Willis LH, Granville EO, Piner LW, Samsa GP, Setji TL, Muehlbauer MJ, Huffman KM, Bales CW, Kraus WE. Effects of exercise training alone vs a combined exercise and nutritional lifestyle intervention on glucose homeostasis in prediabetic individuals: a randomised controlled trial. Diabetologia. 2016 Oct;59(10):2088-98. doi: 10.1007/s00125-016-4051-z. Epub 2016 Jul 15.
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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.
William E Kraus, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Exercise and Diet in people with Pre-Diabetes, run by Duke University 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 11 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 15 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?
Fasting Plasma Glucose (time frame: 3 month control and 6 months intervention). 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 NCT00962962, which also lists 5 linked publications.
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 15 Jul 2014.