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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Combination Product: Behavior intervention of uphill exercise Combination Product: Dietary intervention of exercise before the meal Combination Product: Dietary intervention of uphill exercise Combination Product: Dietary intervention of exercise after the meal Combination Product: Behavior intervention of downhill exercise Combination Product: Behavioral intervention of downhill exercise Combination Product: Behavioral intervention of sedentary no-exercise trial Combination Product: Dietary intervention of eating two meals Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Official Title: Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women
Actual Study Start Date : October 8, 2009
Actual Primary Completion Date : December 5, 2012
Actual Study Completion Date : December 20, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Uphill exercise before the meals
40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal
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

Experimental: Uphill exercise after the meals
40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating 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

Experimental: Downhill exercise before the meals
40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the 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

Experimental: Downhill exercise after the meals
40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating 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

Sham Comparator: Sedentary trial
A trial with no exercise
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930758


Sponsors and Collaborators
University of Michigan
University of Wisconsin, La Crosse
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Katarina T Borer Professor Emerita
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Responsible Party: Dr. Katarina Borer, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03930758    
Other Study ID Numbers: HUM32227/ HUM32700
R15DK082800 ( U.S. NIH Grant/Contract )
M01RR024986 ( Other Grant/Funding Number: Michigan Institute of Clinical and Health Research )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Diabetes Mellitus, Type 2
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Endocrine System Diseases