Focus Type 2 Diabetes Related Chronic Kidney DiseaseDKD-EXTNCT02112071
Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.
A study testing Exercise in people with Focus Type 2 Diabetes Related Chronic Kidney Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The general objective is to investigate the effect of a 12 week walking exercise program on vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers in men and women with pre-dialysis type 2 diabetic kidney disease (DKD). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Focus Type 2 Diabetes Related Chronic Kidney Disease
- 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
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • An individual must be >18 years of age
- Have diagnosed type 2 diabetic mellitus by one of the following criteria:
- o Treated with diet, diet plus oral hypoglycemic agents (for at least one year), or insulin preceded by treatment with oral agents (for at least one year).
- If treated with insulin, the onset of diabetes must have occurred after age of 40 and the body mass index must be >25kg/m2 at the time of diagnosis.
- Diagnosed kidney attributed to diabetes by one of the following criteria:3
- Macroalbuminuria (ACR >300mg/g, or)
Show all 13Show fewer
- Microalbuminuria (ACR between 30-300 mg/g) or in the presence of diabetic retinopathy (although is recognized that about 1/3 of type 2 diabetics do not have retinopathy by fundoscopic exam).
- An elevated ACR should have been confirmed in the absence of urinary tract infections with 2 additional first-void specimens collected over 3-6 months.
- At least 2 of 3 samples should fall within the range of micro or macroalbuminuria.
- An estimated Glomerular filtration rate (GFR) of between 90 ml/min and 30 ml/min measured by (GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units).
- Individuals must be able to provide informed consent
- Perform walking exercise testing on a treadmill
- Be able to participate in a 12-week supervised exercise program.
Who cannot join
- • Patients are currently exercising
- Requiring dialysis
- Have an Hematocrit <30%
- Uncontrolled hypertension (>200/100mmHg)
- Peripheral vascular disease.
- An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease., or having undergone a coronary revascularization within the past 6 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The general objective is to investigate the effect of a 12 week walking exercise program on vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).
- Being tested
- Exercise
- Keywords
- Exercise, Diabetic kidney disease, vascular function, physical function
- Medical subject headings
- Motor Activity, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Blended supervised-home based walking program 3-4 times per week for at least 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | blended supervised-hombased exercise training 3-4 times/week for 12 weeks Receives: Behavioral: Exercise |
| control | No intervention | control group asked to continue usual activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function measured by brachial artery flow mediated vasodilation
Endothelium-mediated change in in vascular tone
Measured: at week 0 and at week 12
Secondary outcomes (5)
arterial stiffness measured by pulse wave velocity
Measured: at week 0 and at week 12
Circulating markers of vascular health
C-reactive protein, isoprostane F2, Asymmetric dimethylarginine
Measured: at week 0 and at week 12
aerobic capacity
Peak oxygen consumption
Measured: at week 0 and at week 12
blood pressure
Measured: at week 0 and at week 12
24-hour albuminuria
assessed in 30 participants measured in milligram per gram creatinine
Measured: at week 0 and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startOct 2009
- Primary completionNov 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus Type 2 Diabetes Related Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulf G Bronas, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112071
- Sponsor's protocol ID
- 0905M66282
- Other IDs
- K23DK082638-04, 22275
- Acronym
- DKD-EXT
- Status last verified
- Jul 2015
- First submitted
- 9 Apr 2014
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.
- ClinicalTrials.gov ID
- NCT02112071
- Acronym / sponsor ID
- DKD-EXT / 0905M66282
- Keywords
- Exercise, Diabetic kidney disease, vascular function, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Apr 2014 (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 general objective is to investigate the effect of a 12 week walking exercise program on vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exerciseblended supervised-hombased exercise training 3-4 times/week for 12 weeks |
| control | No intervention | –control group asked to continue usual activities |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- • An individual must be >18 years of age
- o Treated with diet, diet plus oral hypoglycemic agents (for at least one year), or insulin preceded by treatment with oral agents (for at least one year).
- If treated with insulin, the onset of diabetes must have occurred after age of 40 and the body mass index must be >25kg/m2 at the time of diagnosis.
- Diagnosed kidney attributed to diabetes by one of the following criteria:3
- Macroalbuminuria (ACR >300mg/g, or)
Key exclusion criteria (6 listed)
- • Patients are currently exercising
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 |
|---|---|---|
| ExerciseBlended supervised-home based walking program 3-4 times per week for at least 30 minutes. | Behavioural | Exercise |
Primary outcome
endothelial function measured by brachial artery flow mediated vasodilation
Time frame: at week 0 and at week 12
Endothelium-mediated change in in vascular tone
5 secondary outcomes
arterial stiffness measured by pulse wave velocity
Time frame: at week 0 and at week 12
Circulating markers of vascular health
Time frame: at week 0 and at week 12
aerobic capacity
Time frame: at week 0 and at week 12
blood pressure
Time frame: at week 0 and at week 12
24-hour albuminuria
Time frame: at week 0 and at week 12
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 Jul 2015.
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.
Ulf G Bronas, PhD principal investigator
University of Minnesota
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 Focus Type 2 Diabetes Related Chronic Kidney Disease, run by University of Minnesota 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 13 inclusion and 6 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 Jul 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?
endothelial function measured by brachial artery flow mediated vasodilation (time frame: at week 0 and at week 12). 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 24 Jul 2015.