Preventing Diabetic Osteoporosis With Exercise

NCT03930758 | Completed

• 3 other identifiers: HUM32227/ HUM32700R15DK082800M01RR024986
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The two specific aims of the study were to determine whether:

1. 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. 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• C-terminal propeptide of type I collagen

  Change over time in plasma concentration of c-terminal propeptde of type 1 collagen (ng/ml)

  Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial

• C-terminal telopeptide of type 1 collagen

  Change over time in plasma concentration of c-terminal telopeptide of type 1 collagen (ng/ml)

  Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial

• Osteocalcin

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

  Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial

• Bone-specific alkaline phosphatase

  Change over time in plasma concentration of bone-specific alkaline phosphatase (ng/ml)

  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 Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Study Arms (5)

Uphill exercise before the meals

EXPERIMENTAL

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

Combination Product: Behavior intervention of uphill exercise; Combination Product: Dietary intervention of exercise before the meal

Uphill exercise after the meals

EXPERIMENTAL

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

Combination Product: Dietary intervention of uphill exercise; Combination Product: Dietary intervention of exercise after the meal

Downhill exercise before the meals

EXPERIMENTAL

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

Combination Product: Behavior intervention of downhill exercise; Combination Product: Dietary intervention of exercise before the meal

Downhill exercise after the meals

EXPERIMENTAL

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

Combination Product: Behavioral intervention of downhill exercise; Combination Product: Dietary intervention of exercise after the meal

Sedentary trial

SHAM COMPARATOR

A trial with no exercise

Combination Product: Behavioral intervention of sedentary no-exercise trial; Combination Product: Dietary intervention of eating two meals

Interventions

Behavior intervention of uphill exercise COMBINATION_PRODUCT

40 minutes of uphill exercise

Uphill exercise before the meals

Dietary intervention of exercise before the meal COMBINATION_PRODUCT

40 minutes of uphill exercise completed 1 h before the meal

Uphill exercise before the meals

Dietary intervention of uphill exercise COMBINATION_PRODUCT

40 minutes of uphill exercise

Uphill exercise after the meals

Behavior intervention of downhill exercise COMBINATION_PRODUCT

40 minutes of downhill exercise

Downhill exercise before the meals

Behavioral intervention of downhill exercise COMBINATION_PRODUCT

40 minutes of downhill exercise

Downhill exercise after the meals

Dietary intervention of exercise after the meal COMBINATION_PRODUCT

40 minutes of uphill exercise started 1 hour after gthe meal

Uphill exercise after the meals

Behavioral intervention of sedentary no-exercise trial COMBINATION_PRODUCT

Sedentary no-exercise trial

Sedentary trial

Dietary intervention of eating two meals COMBINATION_PRODUCT

Meals eaten at 10 and 17 h during a sedentary trial

Sedentary trial

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Katarina T Borer

  Professor Emerita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 29, 2019
• Study Start: October 8, 2009
• Primary Completion: December 5, 2012
• Study Completion: December 20, 2012
• Last Updated: April 29, 2019

Record last verified: 2019-04