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Preventing Diabetic Osteoporosis With Exercise

Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03930758
Acronym
DIABETICBONE
Enrollment
15
Registered
2019-04-29
Start date
2009-10-08
Completion date
2012-12-20
Last updated
2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief 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 collagen)) to a greater extent than uphill exercise that provides lower ground-reaction force; 2. 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: 1. 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 2. 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.

Interventions

COMBINATION_PRODUCTBehavior intervention of uphill exercise

40 minutes of uphill exercise

COMBINATION_PRODUCTDietary intervention of exercise before the meal

40 minutes of uphill exercise completed 1 h before the meal

COMBINATION_PRODUCTDietary intervention of uphill exercise

40 minutes of uphill exercise

COMBINATION_PRODUCTDietary intervention of exercise after the meal

40 minutes of uphill exercise started 1 hour after gthe meal

COMBINATION_PRODUCTBehavior intervention of downhill exercise

40 minutes of downhill exercise

COMBINATION_PRODUCTBehavioral intervention of downhill exercise

40 minutes of downhill exercise

COMBINATION_PRODUCTBehavioral intervention of sedentary no-exercise trial

Sedentary no-exercise trial

COMBINATION_PRODUCTDietary intervention of eating two meals

Meals eaten at 10 and 17 h during a sedentary trial

Sponsors

University of Wisconsin, La Crosse
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

postmenopausal type-2 diabetes melllitus age between 50 and 65 exercise less than 20 minutes three times a week

Exclusion criteria

metabolic disease other than type-2 diabetes and hormonally-corrected hypothyroidism musculo-skeletal disability that would preclude exercise smoker do not meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
C-terminal propeptide of type I collagenHourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trialChange over time in plasma concentration of c-terminal propeptde of type 1 collagen (ng/ml)
C-terminal telopeptide of type 1 collagenHourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trialChange over time in plasma concentration of c-terminal telopeptide of type 1 collagen (ng/ml)
OsteocalcinHourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trialChange over time in plasma concentration of osteocalcin (ng/ml)
Bone-specific alkaline phosphataseHourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trialChange over time in plasma concentration of bone-specific alkaline phosphatase (ng/ml)

Secondary

MeasureTime frameDescription
GlucoseHourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trialChange over time in plasma concentration of glucose (mg/dl)
InsulinHourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trialChange over time in plasma concentration of insulin (µU/ml)
Novel PedarDuring two one-hour bouts of the exercise interventionMechanosensitive shoe inserts for measurement of ground reaction force
Dual-energy X-ray radiographyA week prior to the study baselineWhole-body dual-energy X-ray radiography scan
Parathyroid hormoneHourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trialChange over time in plasma concentration of parathyroid hormone (ng/ml)
CortisolHourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trialChange over time in plasma concentration of cortisol (m/L)
Growth hormoneHourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trialChange over time in plasma concentration of growth hormone (ng/ml)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026