Diabetes Mellitus, Type 2DIABETICBONENCT03930758
Preventing Diabetic Osteoporosis With Exercise
A study testing Behavior intervention of uphill exercise, Dietary intervention of exercise before the meal and Dietary intervention of uphill exercise in people with Diabetes Mellitus, Type 2, run by University of Michigan.
Trial summary
The two specific aims of the study were to determine whether: 1. Greater mechanical loading of downhill exercise will increase the osteogenic index (ratio between CICP, the marker of bone formation (c-terminal propeptide of type I collagen, and CTX, the marker of bone resorption (c terminal telopeptide of type I… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Behavior intervention of uphill exercise, Dietary intervention of exercise before the meal and Dietary intervention of uphill exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2009to 20 Dec 2012
- 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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal type-2 diabetes melllitus age between 50 and 65 exercise less than 20 minutes three times a week
Who cannot join
- metabolic disease other than type-2 diabetes and hormonally-corrected hypothyroidism musculo-skeletal disability that would preclude exercise smoker do not meet inclusion criteria
About this study
Official title: Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women
The two specific aims of the study were to determine whether:
- Greater mechanical loading of downhill exercise will increase the osteogenic index (ratio between CICP, the marker of bone formation (c-terminal propeptide of type I collagen, and CTX, the marker of bone resorption (c terminal telopeptide of type I collagen)) to a greater extent than uphill exercise that provides lower ground-reaction force;
- Exercise after the meals will induce greater osteogenic response than exercise pefore the meals as it is known that meal eating during daytime inhibits bvone resorption markers.
Read the detailed description
The study addresses the problem that postmenopausal women with type 2 diabetes have a higher incidence of bone breaks despite their often normal bone mineral density (BMD).
The investigators pursued two hypotheses, that:
- 40-minute bout of downhill exercise will increase the CICP/CTX osteogenic index to a greater extent than the same amount of uphill exercise; and
- Performing exercise one hour after the meals will be more osteogenic than exercise before the meals.
Subjects were 15 postmenopausal women with type 2 diabetes, age 57.7 years, BMI 27.2 kg/m2 who were randomly assigned to two out of 5 trials:
Uphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), Downhill exercise after the meals (DAM), and Sedentary, no-exercise, trial (SED). All subjects signed an informed consent approved by the University of Michigan Medical School Institutional Review Board. Subjects had their BMD measured with DXA at the outset.
Weight-maintenance meals contained 50% carbohydrate, 15% protein, and 25% fat and were provided at 10 h and 17 h. Exercise (40 minutes at 50% of maximal effort) on either uphill (+6o slope) or downhill treadmill (-6o slope) was performed either before the two meals, at 9 h and 16 h, respectively, or after the meals. at 11 h and 18 h, respectively.
Blood was drawn through an intravenous catheter from ante-cubital vein at hourly intervals between 8 and 20 h with two additional blood draws at 0 h and 6 h the next morning. Blood was treated with protease inhibitors, and plasma, frozen at -80o C, was used to measure bone markers, CICP, CTX, osteocalcin , and bone-specific alkaline phosphatase using Millipore chemoluminescen reagents, glucose by glucose oxidase, and hormones insulin, cortisol, parathyroid hormone (PTH) , and growth hormone (GH) by radio-immunoassays..
Mixed-model ANOVA was used for analysis of outcome measures where the trial procedures served as fixed variable and individual subjects as intercept variables.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Behavior intervention of uphill exercise, Dietary intervention of exercise before the meal, Dietary intervention of uphill exercise, Dietary intervention of exercise after the meal, Behavior intervention of downhill exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior intervention of uphill exerciseCombination product
40 minutes of uphill exercise
Dietary intervention of exercise before the mealCombination product
40 minutes of uphill exercise completed 1 h before the meal
Dietary intervention of uphill exerciseCombination product
40 minutes of uphill exercise
Dietary intervention of exercise after the mealCombination product
40 minutes of uphill exercise started 1 hour after gthe meal
Behavior intervention of downhill exerciseCombination product
40 minutes of downhill exercise
Dietary intervention of exercise before the mealCombination product
40 minutes of downhill exercise completed 1 hour before the meal
Behavioral intervention of downhill exerciseCombination product
40 minutes of downhill exercise
Dietary intervention of exercise after the mealCombination product
40 minutes of downhill exercise started 1 hour after the meal
Behavioral intervention of sedentary no-exercise trialCombination product
Sedentary no-exercise trial
Dietary intervention of eating two mealsCombination product
Meals eaten at 10 and 17 h during a sedentary trial
| Study group | Role | What they receive |
|---|---|---|
| Uphill exercise before the meals | Experimental | 40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal Receives: Combination Product: Behavior intervention of uphill exercise; Combination Product: Dietary intervention of exercise before the meal |
| Uphill exercise after the meals | Experimental | 40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal Receives: Combination Product: Dietary intervention of uphill exercise; Combination Product: Dietary intervention of exercise after the meal |
| Downhill exercise before the meals | Experimental | 40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal Receives: Combination Product: Behavior intervention of downhill exercise; Combination Product: Dietary intervention of exercise before the meal |
| Downhill exercise after the meals | Experimental | 40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal Receives: Combination Product: Behavioral intervention of downhill exercise; Combination Product: Dietary intervention of exercise after the meal |
| Sedentary trial | Sham comparator | A trial with no exercise Receives: Combination Product: Behavioral intervention of sedentary no-exercise trial; Combination Product: Dietary intervention of eating two meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-terminal propeptide of type I collagen
Change over time in plasma concentration of c-terminal propeptde of type 1 collagen (ng/ml)
Measured: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
C-terminal telopeptide of type 1 collagen
Change over time in plasma concentration of c-terminal telopeptide of type 1 collagen (ng/ml)
Measured: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Osteocalcin
Change over time in plasma concentration of osteocalcin (ng/ml)
Measured: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Bone-specific alkaline phosphatase
Change over time in plasma concentration of bone-specific alkaline phosphatase (ng/ml)
Measured: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Secondary outcomes (7)
Insulin
Change over time in plasma concentration of insulin (µU/ml)
Measured: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Parathyroid hormone
Change over time in plasma concentration of parathyroid hormone (ng/ml)
Measured: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Cortisol
Change over time in plasma concentration of cortisol (m/L)
Measured: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Growth hormone
Change over time in plasma concentration of growth hormone (ng/ml)
Measured: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Glucose
Change over time in plasma concentration of glucose (mg/dl)
Measured: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Dual-energy X-ray radiography
Whole-body dual-energy X-ray radiography scan
Measured: A week prior to the study baseline
Novel Pedar
Mechanosensitive shoe inserts for measurement of ground reaction force
Measured: During two one-hour bouts of the exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start8 Oct 2009
- Primary completion5 Dec 2012
- Study completion20 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Study consisted of 5 experimental trials (or arms), of which 4 were compared to a sedentary (or control) arm. The five trials were: Uphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), and Downhill exercise after the meals (DAM), and the Sedentary (Sed) or control trial.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, La Crosse, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Dr. Katarina Borer, University of Michigan
- Investigators
- Katarina T Borer, Principal investigator, Professor Emerita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930758
- Sponsor's protocol ID
- HUM32227/ HUM32700
- Other IDs
- R15DK082800, M01RR024986
- Acronym
- DIABETICBONE
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03930758
- Acronym / sponsor ID
- DIABETICBONE / HUM32227/ HUM32700
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Wisconsin, La Crosse, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Oct 2009 (actual)
- Primary completion
- 5 Dec 2012 (actual)
- Study completion
- 20 Dec 2012 (actual)
- First posted
- 29 Apr 2019 (actual)
- 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 two specific aims of the study were to determine whether:
- Greater mechanical loading of downhill exercise will increase the osteogenic index (ratio between CICP, the marker of bone formation (c-terminal propeptide of type I collagen, and CTX, the marker of bone resorption (c terminal telopeptide of type I collagen)) to a greater extent than uphill exercise that provides lower ground-reaction force;
- Exercise after the meals will induce greater osteogenic response than exercise pefore the meals as it is known that meal eating during daytime inhibits bvone resorption markers.
Detailed description
The study addresses the problem that postmenopausal women with type 2 diabetes have a higher incidence of bone breaks despite their often normal bone mineral density (BMD).
The investigators pursued two hypotheses, that:
- 40-minute bout of downhill exercise will increase the CICP/CTX osteogenic index to a greater extent than the same amount of uphill exercise; and
- Performing exercise one hour after the meals will be more osteogenic than exercise before the meals.
Subjects were 15 postmenopausal women with type 2 diabetes, age 57.7 years, BMI 27.2 kg/m2 who were randomly assigned to two out of 5 trials:
Uphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), Downhill exercise after the meals (DAM), and Sedentary, no-exercise, trial (SED). All subjects signed an informed consent approved by the University of Michigan Medical School Institutional Review Board. Subjects had their BMD measured with DXA at the outset.
Weight-maintenance meals contained 50% carbohydrate, 15% protein, and 25% fat and were provided at 10 h and 17 h. Exercise (40 minutes at 50% of maximal effort) on either uphill (+6o slope) or downhill treadmill (-6o slope) was performed either before the two meals, at 9 h and 16 h, respectively, or after the meals. at 11 h and 18 h, respectively.
Blood was drawn through an intravenous catheter from ante-cubital vein at hourly intervals between 8 and 20 h with two additional blood draws at 0 h and 6 h the next morning. Blood was treated with protease inhibitors, and plasma, frozen at -80o C, was used to measure bone markers, CICP, CTX, osteocalcin , and bone-specific alkaline phosphatase using Millipore chemoluminescen reagents, glucose by glucose oxidase, and hormones insulin, cortisol, parathyroid hormone (PTH) , and growth hormone (GH) by radio-immunoassays..
Mixed-model ANOVA was used for analysis of outcome measures where the trial procedures served as fixed variable and individual subjects as intercept variables.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Study consisted of 5 experimental trials (or arms), of which 4 were compared to a sedentary (or control) arm. The five trials were: Uphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), and Downhill exercise after the meals (DAM), and the Sedentary (Sed) or control trial.
| Arm | Type | Receives |
|---|---|---|
| Uphill exercise before the meals | Experimental | Combination Product: Behavior intervention of uphill exercise, Combination Product: Dietary intervention of exercise before the meal40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal |
| Uphill exercise after the meals | Experimental | Combination Product: Dietary intervention of uphill exercise, Combination Product: Dietary intervention of exercise after the meal40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal |
| Downhill exercise before the meals | Experimental | Combination Product: Behavior intervention of downhill exercise, Combination Product: Dietary intervention of exercise before the meal40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal |
| Downhill exercise after the meals | Experimental | Combination Product: Behavioral intervention of downhill exercise, Combination Product: Dietary intervention of exercise after the meal40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal |
| Sedentary trial | Sham comparator | Combination Product: Behavioral intervention of sedentary no-exercise trial, Combination Product: Dietary intervention of eating two mealsA trial with no exercise |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- postmenopausal type-2 diabetes melllitus age between 50 and 65 exercise less than 20 minutes three times a week
Key exclusion criteria (1 listed)
- metabolic disease other than type-2 diabetes and hormonally-corrected hypothyroidism musculo-skeletal disability that would preclude exercise smoker do not meet inclusion criteria
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 |
|---|---|---|
| Behavior intervention of uphill exercise40 minutes of uphill exercise | Combination product | Uphill exercise before the meals |
| Dietary intervention of exercise before the meal40 minutes of uphill exercise completed 1 h before the meal | Combination product | Uphill exercise before the meals |
| Dietary intervention of uphill exercise40 minutes of uphill exercise | Combination product | Uphill exercise after the meals |
| Dietary intervention of exercise after the meal40 minutes of uphill exercise started 1 hour after gthe meal | Combination product | Uphill exercise after the meals |
| Behavior intervention of downhill exercise40 minutes of downhill exercise | Combination product | Downhill exercise before the meals |
| Dietary intervention of exercise before the meal40 minutes of downhill exercise completed 1 hour before the meal | Combination product | Downhill exercise before the meals |
| Behavioral intervention of downhill exercise40 minutes of downhill exercise | Combination product | Downhill exercise after the meals |
| Dietary intervention of exercise after the meal40 minutes of downhill exercise started 1 hour after the meal | Combination product | Downhill exercise after the meals |
| Behavioral intervention of sedentary no-exercise trialSedentary no-exercise trial | Combination product | Sedentary trial |
| Dietary intervention of eating two mealsMeals eaten at 10 and 17 h during a sedentary trial | Combination product | Sedentary trial |
Primary outcome
C-terminal propeptide of type I collagen
Time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of c-terminal propeptde of type 1 collagen (ng/ml)
C-terminal telopeptide of type 1 collagen
Time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of c-terminal telopeptide of type 1 collagen (ng/ml)
Osteocalcin
Time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of osteocalcin (ng/ml)
Bone-specific alkaline phosphatase
Time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of bone-specific alkaline phosphatase (ng/ml)
7 secondary outcomes
Insulin
Time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Parathyroid hormone
Time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Cortisol
Time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Growth hormone
Time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Glucose
Time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Dual-energy X-ray radiography
Time frame: A week prior to the study baseline
Novel Pedar
Time frame: During two one-hour bouts of the exercise 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 29 Apr 2019.
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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.
Katarina T Borer principal investigator
Professor Emerita
Questions about this trial
What is this clinical trial studying?
A study testing Behavior intervention of uphill exercise, Dietary intervention of exercise before the meal and Dietary intervention of uphill exercise in people with Diabetes Mellitus, Type 2, run by University of Michigan.
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 1 inclusion and 1 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 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
C-terminal propeptide of type I collagen (time frame: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial). The study lists 4 primary outcomes in all. 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 29 Apr 2019.