Preventing Diabetic Osteoporosis With Exercise

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Combination Product: Behavior intervention of uphill exercise; Combination Product: Behavioral intervention of downhill exercise; Combination Product: Dietary intervention of uphill exercise; Combination Product: Behavioral intervention of sedentary no-exercise trial; Combination Product: Behavior intervention of downhill exercise; Combination Product: Dietary intervention of exercise before the meal; Combination Product: Dietary intervention of exercise after the meal; Combination Product: Dietary intervention of eating two meals

• Registration Number: NCT03930758
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2009-10-08
• Primary Completion: 2012-12-05
• Study Completion: 2012-12-20
• Status Verified: 2019-04
• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-26
• Last Update Submitted: 2019-04-26
• Study First Posted: 2019-04-29
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Uphill exercise before the meals	Dietary intervention of exercise before the meal	40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal
Uphill exercise after the meals	Dietary intervention of exercise after the meal	40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal
Uphill exercise before the meals	Behavior intervention of uphill exercise	40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal
Downhill exercise after the meals	Behavioral intervention of downhill exercise	40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal
Uphill exercise after the meals	Dietary intervention of uphill exercise	40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal
Downhill exercise before the meals	Dietary intervention of exercise before the meal	40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal
Sedentary trial	Behavioral intervention of sedentary no-exercise trial	A trial with no exercise
Downhill exercise before the meals	Behavior intervention of downhill exercise	40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal
Downhill exercise after the meals	Dietary intervention of exercise after the meal	40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal
Sedentary trial	Dietary intervention of eating two meals	A trial with no exercise

Primary Outcome Measures

Name	Time	Method
C-terminal telopeptide of type 1 collagen	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)
C-terminal propeptide of type I collagen	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)
Osteocalcin	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	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)

Secondary Outcome Measures

Name	Time	Method
Cortisol	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)
Glucose	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)
Insulin	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)
Parathyroid hormone	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)
Dual-energy X-ray radiography	A week prior to the study baseline	Whole-body dual-energy X-ray radiography scan
Growth hormone	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)
Novel Pedar	During two one-hour bouts of the exercise intervention	Mechanosensitive shoe inserts for measurement of ground reaction force