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Preventing Diabetic Osteoporosis With Exercise (DIABETICBONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930758
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
University of Wisconsin, La Crosse
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Dr. Katarina Borer, University of Michigan

Tracking Information
First Submitted Date  ICMJE April 19, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date  ICMJE October 8, 2009
Actual Primary Completion Date December 5, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Dual-energy X-ray radiography [ Time Frame: A week prior to the study baseline ]
    Whole-body dual-energy X-ray radiography scan
  • Novel Pedar [ Time Frame: During two one-hour bouts of the exercise intervention ]
    Mechanosensitive shoe inserts for measurement of ground reaction force
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Diabetic Osteoporosis With Exercise
Official Title  ICMJE Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Combination Product: Behavior intervention of uphill exercise
    40 minutes of uphill exercise
  • Combination Product: Dietary intervention of exercise before the meal
    40 minutes of uphill exercise completed 1 h before the meal
  • Combination Product: Dietary intervention of uphill exercise
    40 minutes of uphill exercise
  • Combination Product: Dietary intervention of exercise after the meal
    40 minutes of uphill exercise started 1 hour after gthe meal
  • Combination Product: Behavior intervention of downhill exercise
    40 minutes of downhill exercise
  • Combination Product: Dietary intervention of exercise before the meal
    40 minutes of downhill exercise completed 1 hour before the meal
  • Combination Product: Behavioral intervention of downhill exercise
    40 minutes of downhill exercise
  • Combination Product: Dietary intervention of exercise after the meal
    40 minutes of downhill exercise started 1 hour after the meal
  • Combination Product: Behavioral intervention of sedentary no-exercise trial
    Sedentary no-exercise trial
  • Combination Product: Dietary intervention of eating two meals
    Meals eaten at 10 and 17 h during a sedentary trial
Study Arms  ICMJE
  • Experimental: Uphill exercise before the meals
    40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal
    Interventions:
    • Combination Product: Behavior intervention of uphill exercise
    • Combination Product: Dietary intervention of exercise before the meal
  • Experimental: Uphill exercise after the meals
    40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal
    Interventions:
    • Combination Product: Dietary intervention of uphill exercise
    • Combination Product: Dietary intervention of exercise after the meal
  • Experimental: Downhill exercise before the meals
    40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal
    Interventions:
    • Combination Product: Behavior intervention of downhill exercise
    • Combination Product: Dietary intervention of exercise before the meal
  • Experimental: Downhill exercise after the meals
    40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal
    Interventions:
    • Combination Product: Behavioral intervention of downhill exercise
    • Combination Product: Dietary intervention of exercise after the meal
  • Sham Comparator: Sedentary trial
    A trial with no exercise
    Interventions:
    • Combination Product: Behavioral intervention of sedentary no-exercise trial
    • Combination Product: Dietary intervention of eating two meals
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2019)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 20, 2012
Actual Primary Completion Date December 5, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930758
Other Study ID Numbers  ICMJE HUM32227/ HUM32700
R15DK082800 ( U.S. NIH Grant/Contract )
M01RR024986 ( Other Grant/Funding Number: Michigan Institute of Clinical and Health Research )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Katarina Borer, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE
  • University of Wisconsin, La Crosse
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Katarina T Borer Professor Emerita
PRS Account University of Michigan
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP