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Preventing Diabetic Osteoporosis With Exercise (DIABETICBONE)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavior intervention of uphill exercise
Dietary intervention of exercise before the meal
Dietary intervention of uphill exercise
Dietary intervention of exercise after the meal
Behavior intervention of downhill exercise
Dietary intervention of exercise before the meal
Behavioral intervention of downhill exercise
Dietary intervention of exercise after the meal
Behavioral intervention of sedentary no-exercise trial
Dietary intervention of eating two meals
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Uphill exercise before the meals

    Uphill exercise after the meals

    Downhill exercise before the meals

    Downhill exercise after the meals

    Sedentary trial

    Arm Description

    40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal

    40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal

    40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal

    40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal

    A trial with no exercise

    Outcomes

    Primary Outcome Measures

    C-terminal propeptide of type I collagen
    Change over time in plasma concentration of c-terminal propeptde of type 1 collagen (ng/ml)
    C-terminal telopeptide of type 1 collagen
    Change over time in plasma concentration of c-terminal telopeptide of type 1 collagen (ng/ml)
    Osteocalcin
    Change over time in plasma concentration of osteocalcin (ng/ml)
    Bone-specific alkaline phosphatase
    Change over time in plasma concentration of bone-specific alkaline phosphatase (ng/ml)

    Secondary Outcome Measures

    Insulin
    Change over time in plasma concentration of insulin (µU/ml)
    Parathyroid hormone
    Change over time in plasma concentration of parathyroid hormone (ng/ml)
    Cortisol
    Change over time in plasma concentration of cortisol (m/L)
    Growth hormone
    Change over time in plasma concentration of growth hormone (ng/ml)
    Glucose
    Change over time in plasma concentration of glucose (mg/dl)
    Dual-energy X-ray radiography
    Whole-body dual-energy X-ray radiography scan
    Novel Pedar
    Mechanosensitive shoe inserts for measurement of ground reaction force

    Full Information

    First Posted
    April 19, 2019
    Last Updated
    April 26, 2019
    Sponsor
    University of Michigan
    Collaborators
    University of Wisconsin, La Crosse, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03930758
    Brief Title
    Preventing Diabetic Osteoporosis With Exercise
    Acronym
    DIABETICBONE
    Official Title
    Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 8, 2009 (Actual)
    Primary Completion Date
    December 5, 2012 (Actual)
    Study Completion Date
    December 20, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan
    Collaborators
    University of Wisconsin, La Crosse, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The two specific aims of the study were to determine whether: 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; 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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    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)
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Uphill exercise before the meals
    Arm Type
    Experimental
    Arm Description
    40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal
    Arm Title
    Uphill exercise after the meals
    Arm Type
    Experimental
    Arm Description
    40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal
    Arm Title
    Downhill exercise before the meals
    Arm Type
    Experimental
    Arm Description
    40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal
    Arm Title
    Downhill exercise after the meals
    Arm Type
    Experimental
    Arm Description
    40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal
    Arm Title
    Sedentary trial
    Arm Type
    Sham Comparator
    Arm Description
    A trial with no exercise
    Intervention Type
    Combination Product
    Intervention Name(s)
    Behavior intervention of uphill exercise
    Intervention Description
    40 minutes of uphill exercise
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dietary intervention of exercise before the meal
    Intervention Description
    40 minutes of uphill exercise completed 1 h before the meal
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dietary intervention of uphill exercise
    Intervention Description
    40 minutes of uphill exercise
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dietary intervention of exercise after the meal
    Intervention Description
    40 minutes of uphill exercise started 1 hour after gthe meal
    Intervention Type
    Combination Product
    Intervention Name(s)
    Behavior intervention of downhill exercise
    Intervention Description
    40 minutes of downhill exercise
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dietary intervention of exercise before the meal
    Intervention Description
    40 minutes of downhill exercise completed 1 hour before the meal
    Intervention Type
    Combination Product
    Intervention Name(s)
    Behavioral intervention of downhill exercise
    Intervention Description
    40 minutes of downhill exercise
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dietary intervention of exercise after the meal
    Intervention Description
    40 minutes of downhill exercise started 1 hour after the meal
    Intervention Type
    Combination Product
    Intervention Name(s)
    Behavioral intervention of sedentary no-exercise trial
    Intervention Description
    Sedentary no-exercise trial
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dietary intervention of eating two meals
    Intervention Description
    Meals eaten at 10 and 17 h during a sedentary trial
    Primary Outcome Measure Information:
    Title
    C-terminal propeptide of type I collagen
    Description
    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
    Title
    C-terminal telopeptide of type 1 collagen
    Description
    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
    Title
    Osteocalcin
    Description
    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
    Title
    Bone-specific alkaline phosphatase
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Insulin
    Description
    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
    Title
    Parathyroid hormone
    Description
    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
    Title
    Cortisol
    Description
    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
    Title
    Growth hormone
    Description
    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
    Title
    Glucose
    Description
    Change over time in plasma concentration of glucose (mg/dl)
    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
    Title
    Dual-energy X-ray radiography
    Description
    Whole-body dual-energy X-ray radiography scan
    Time Frame
    A week prior to the study baseline
    Title
    Novel Pedar
    Description
    Mechanosensitive shoe inserts for measurement of ground reaction force
    Time Frame
    During two one-hour bouts of the exercise intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katarina T Borer
    Organizational Affiliation
    Professor Emerita
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Preventing Diabetic Osteoporosis With Exercise

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