Type 2 DiabetesOGTTNCT00972452
Blood Flow Responses to an Oral Glucose Tolerance Test in Type 2 Diabetes
A study testing Exercise in people with Type 2 Diabetes and Insulin Resistance, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The investigators wish to determine whether a short period of exercise training (5-10 days) improves the metabolic and cardiovascular response of people with or at risk of developing type 2 diabetes to eating a meal. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Insulin Resistance
- What is being tested?
- 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
- Aug 2009to Sep 2010
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insulin resistant: diagnosed with pre-diabetes or fasting blood glucose >/= 100 mg/dL
- T2D: diagnosed by primary care physician
- BMI: less than 43 kg/m2
- Age: 30-65
Who cannot join
- Smoking
- Insulin use (other than once daily)
- Underlying conditions that limit ability to exercise safely
- Recent weight gain or loss (> 5% of body weight in 3 months)
- Physically active (> 30 min aerobic exercise, 2 d/wk)
- Recent (< 3 mo) changes in medication use or dose
Show all 9Show fewer
- Uncontrolled T2D (HbA1c > 10%)
- Advanced retinopathy or neuropathy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals
The investigators wish to determine whether a short period of exercise training (5-10 days) improves the metabolic and cardiovascular response of people with or at risk of developing type 2 diabetes to eating a meal. In healthy people, blood flow to skeletal muscles increases after eating a meal, and this helps to regulate blood sugar levels by delivering blood sugar to muscles where it can be stored or metabolized. In people with or at risk of type 2 diabetes, blood flow does not increase as much after eating a meal, and this may contribute to elevated blood sugar concentrations observed in these individuals. The investigators wish to determine whether exercise can improve this response.
Read the detailed description
Insulin resistance is characterized by decreased sensitivity to the metabolic actions of insulin (glucose disposal) and is a hallmark of obesity and type 2 diabetes (T2D). Insulin resistance is also a prominent component of cardiovascular diseases (CVD), including hypertension, coronary artery disease, and atherosclerosis, which are characterized by endothelial dysfunction. Insulin stimulates two distinct signaling pathways in the endothelium. One produces the vasodilator nitric oxide (NO) through the insulin receptor substrate-1(IRS-1)/endothelial NO synthase (eNOS) pathway while the other stimulates production of endothelin-1 (ET-1), a vasoconstrictor, through the mitogen activated protein kinase (MAPK) pathway. Insulin-mediated glucose disposal is largely dependent upon the vasodilatory effects of insulin; however, in T2D, insulin-stimulated dilation is impaired as a result of an imbalance in NO and ET-1 production, leading to diminished microvascular perfusion and skeletal muscle glucose delivery in response to insulin. The effects of exercise on insulin signaling/action in the endothelium are not fully understood. The purpose of this study is determine the acute effects of aerobic exercise training on cardiometabolic responses to meal ingestion in individuals with insulin resistance or T2D. We will recruit 30 previously sedentary (<60 minutes of planned exercise/week) men and women with insulin resistance (pre-diabetes) or T2D for participation in this study. Participants will undergo a screening procedure, including telephone screening and physical examination, as well as determination of body composition and fitness. Participants will be asked to complete 5-10 days of supervised exercise training and will undergo testing to assess cardiovascular and metabolic responses to an oral glucose tolerance test, including muscle sympathetic nerve activity, blood flow, and circulating glucose and insulin concentrations at baseline and following training. In addition, participants will use continuous glucose monitoring systems for 3 days at baseline and during 3 days of exercise training to assess the effects of acute exercise on postprandial glucose responses to mixed meals in free-living individuals. The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.
- Conditions
- Type 2 Diabetes, Insulin Resistance
- Being tested
- Exercise
- Keywords
- Type II Diabetes, Insulin Resistance, Exercise, Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
short period of exercise training (5-10 days)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 5-10d exercise training Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Kansas Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- John P Thyfault, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972452
- Sponsor's protocol ID
- MUIRB1135317
- Acronym
- OGTT
- Status last verified
- Sep 2015
- First submitted
- 4 Sep 2009
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mikus CR, Oberlin DJ, Libla J, Boyle LJ, Thyfault JP. Glycaemic control is improved by 7 days of aerobic exercise training in patients with type 2 diabetes. Diabetologia. 2012 May;55(5):1417-23. doi: 10.1007/s00125-012-2490-8. Epub 2012 Feb 4.
PubMed 22311420Mikus CR, Fairfax ST, Libla JL, Boyle LJ, Vianna LC, Oberlin DJ, Uptergrove GM, Deo SH, Kim A, Kanaley JA, Fadel PJ, Thyfault JP. Seven days of aerobic exercise training improves conduit artery blood flow following glucose ingestion in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Sep;111(3):657-64. doi: 10.1152/japplphysiol.00489.2011. Epub 2011 Jul 7.
PubMed 21737826
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals
- ClinicalTrials.gov ID
- NCT00972452
- Acronym / sponsor ID
- OGTT / MUIRB1135317
- Conditions
- Type 2 Diabetes, Insulin Resistance
- Keywords
- Type II Diabetes, Insulin Resistance, Exercise, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Sep 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 investigators wish to determine whether a short period of exercise training (5-10 days) improves the metabolic and cardiovascular response of people with or at risk of developing type 2 diabetes to eating a meal. In healthy people, blood flow to skeletal muscles increases after eating a meal, and this helps to regulate blood sugar levels by delivering blood sugar to muscles where it can be stored or metabolized. In people with or at risk of type 2 diabetes, blood flow does not increase as much after eating a meal, and this may contribute to elevated blood sugar concentrations observed in these individuals. The investigators wish to determine whether exercise can improve this response.
Detailed description
Insulin resistance is characterized by decreased sensitivity to the metabolic actions of insulin (glucose disposal) and is a hallmark of obesity and type 2 diabetes (T2D). Insulin resistance is also a prominent component of cardiovascular diseases (CVD), including hypertension, coronary artery disease, and atherosclerosis, which are characterized by endothelial dysfunction. Insulin stimulates two distinct signaling pathways in the endothelium. One produces the vasodilator nitric oxide (NO) through the insulin receptor substrate-1(IRS-1)/endothelial NO synthase (eNOS) pathway while the other stimulates production of endothelin-1 (ET-1), a vasoconstrictor, through the mitogen activated protein kinase (MAPK) pathway. Insulin-mediated glucose disposal is largely dependent upon the vasodilatory effects of insulin; however, in T2D, insulin-stimulated dilation is impaired as a result of an imbalance in NO and ET-1 production, leading to diminished microvascular perfusion and skeletal muscle glucose delivery in response to insulin. The effects of exercise on insulin signaling/action in the endothelium are not fully understood. The purpose of this study is determine the acute effects of aerobic exercise training on cardiometabolic responses to meal ingestion in individuals with insulin resistance or T2D. We will recruit 30 previously sedentary (<60 minutes of planned exercise/week) men and women with insulin resistance (pre-diabetes) or T2D for participation in this study. Participants will undergo a screening procedure, including telephone screening and physical examination, as well as determination of body composition and fitness. Participants will be asked to complete 5-10 days of supervised exercise training and will undergo testing to assess cardiovascular and metabolic responses to an oral glucose tolerance test, including muscle sympathetic nerve activity, blood flow, and circulating glucose and insulin concentrations at baseline and following training. In addition, participants will use continuous glucose monitoring systems for 3 days at baseline and during 3 days of exercise training to assess the effects of acute exercise on postprandial glucose responses to mixed meals in free-living individuals. The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise5-10d exercise training |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Insulin resistant: diagnosed with pre-diabetes or fasting blood glucose >/= 100 mg/dL
- T2D: diagnosed by primary care physician
- BMI: less than 43 kg/m2
- Age: 30-65
Key exclusion criteria (9 listed)
- Smoking
- Insulin use (other than once daily)
- Underlying conditions that limit ability to exercise safely
- Recent weight gain or loss (> 5% of body weight in 3 months)
- Physically active (> 30 min aerobic exercise, 2 d/wk)
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 |
|---|---|---|
| Exerciseshort period of exercise training (5-10 days) | Behavioural | Exercise |
Primary outcome
The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.
Time frame: 2 hours
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 24 Sep 2015.
- Derived from this study: PubMed 22311420Mikus CR, Oberlin DJ, Libla J, Boyle LJ, Thyfault JP. Glycaemic control is improved by 7 days of aerobic exercise training in patients with type 2 diabetes. Diabetologia. 2012 May;55(5):1417-23. doi: 10.1007/s00125-012-2490-8. Epub 2012 Feb 4.
- Derived from this study: PubMed 21737826Mikus CR, Fairfax ST, Libla JL, Boyle LJ, Vianna LC, Oberlin DJ, Uptergrove GM, Deo SH, Kim A, Kanaley JA, Fadel PJ, Thyfault JP. Seven days of aerobic exercise training improves conduit artery blood flow following glucose ingestion in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Sep;111(3):657-64. doi: 10.1152/japplphysiol.00489.2011. Epub 2011 Jul 7.
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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.
John P Thyfault, PhD principal investigator
University of Kansas 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 in people with Type 2 Diabetes and Insulin Resistance, run by University of Kansas 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 4 inclusion and 9 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 24 Sep 2015. 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?
The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D. (time frame: 2 hours). 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 NCT00972452, which also lists 2 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 24 Sep 2015.