Behavior intervention of uphill exercise
Combination Product40 minutes of uphill exercise
NCT Number: NCT03930758
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.
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Notify Me50 year–65 year
Female
Interventional
Not applicable
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
40 minutes of uphill exercise
40 minutes of uphill exercise completed 1 h before the meal
40 minutes of uphill exercise
40 minutes of uphill exercise started 1 hour after gthe meal
40 minutes of downhill exercise
40 minutes of downhill exercise
Sedentary no-exercise trial
Meals eaten at 10 and 17 h during a sedentary trial
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)
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)
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)
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)
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 insulin (µU/ml)
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 parathyroid hormone (ng/ml)
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 cortisol (m/L)
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 growth hormone (ng/ml)
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 glucose (mg/dl)
Time frame: A week prior to the study baseline
Whole-body dual-energy X-ray radiography scan
Time frame: During two one-hour bouts of the exercise intervention
Mechanosensitive shoe inserts for measurement of ground reaction force
University of Michigan
Other
Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women
Acronym: DIABETICBONE
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