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Completed

NCT Number: NCT03930758

Preventing Diabetic Osteoporosis With Exercise

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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Key information

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

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

Treatment and study plan

Behavior intervention of uphill exercise

Combination Product

40 minutes of uphill exercise

Dietary intervention of exercise before the meal

Combination Product

40 minutes of uphill exercise completed 1 h before the meal

Dietary intervention of uphill exercise

Combination Product

40 minutes of uphill exercise

Dietary intervention of exercise after the meal

Combination Product

40 minutes of uphill exercise started 1 hour after gthe meal

Behavior intervention of downhill exercise

Combination Product

40 minutes of downhill exercise

Behavioral intervention of downhill exercise

Combination Product

40 minutes of downhill exercise

Behavioral intervention of sedentary no-exercise trial

Combination Product

Sedentary no-exercise trial

Dietary intervention of eating two meals

Combination Product

Meals eaten at 10 and 17 h during a sedentary trial

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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

    Change over time in plasma concentration of insulin (µU/ml)

  2. 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

    Change over time in plasma concentration of parathyroid hormone (ng/ml)

  3. 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

    Change over time in plasma concentration of cortisol (m/L)

  4. 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

    Change over time in plasma concentration of growth hormone (ng/ml)

  5. 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

    Change over time in plasma concentration of glucose (mg/dl)

  6. Dual-energy X-ray radiography

    Time frame: A week prior to the study baseline

    Whole-body dual-energy X-ray radiography scan

  7. Novel Pedar

    Time frame: During two one-hour bouts of the exercise intervention

    Mechanosensitive shoe inserts for measurement of ground reaction force

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Wisconsin, La Crosse

Registry information

Official study title

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

Acronym: DIABETICBONE

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2019
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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