Preventing Diabetic Osteoporosis With Exercise

Diabetes Mellitus, Type 2 Clinical Trial

— DIABETICBONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930758
• Other study ID #: HUM32227/ HUM32700
• Secondary ID: R15DK082800M01RR
• Status: Completed
• Phase: N/A
• Start date: October 8, 2009
• Est. completion date: December 20, 2012

Study information

• Verified date: April 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 20, 2012
• Est. primary completion date: December 5, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Osteoporosis

Intervention

Combination Product:
• Behavior intervention of uphill exercise
40 minutes of uphill exercise
• Dietary intervention of exercise before the meal
40 minutes of uphill exercise completed 1 h before the meal
• Dietary intervention of uphill exercise
40 minutes of uphill exercise
• Dietary intervention of exercise after the meal
40 minutes of uphill exercise started 1 hour after gthe meal
• Behavior intervention of downhill exercise
40 minutes of downhill exercise
• Dietary intervention of exercise before the meal
40 minutes of downhill exercise completed 1 hour before the meal
• Behavioral intervention of downhill exercise
40 minutes of downhill exercise
• Dietary intervention of exercise after the meal
40 minutes of downhill exercise started 1 hour after the meal
• Behavioral intervention of sedentary no-exercise trial
Sedentary no-exercise trial
• Dietary intervention of eating two meals
Meals eaten at 10 and 17 h during a sedentary trial

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Wisconsin, La Crosse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Insulin	Change over time in plasma concentration of insulin (µU/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	Parathyroid hormone	Change over time in plasma concentration of parathyroid hormone (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	Cortisol	Change over time in plasma concentration of cortisol (m/L)	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	Growth hormone	Change over time in plasma concentration of growth hormone (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	Glucose	Change over time in plasma concentration of glucose (mg/dl)	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	Dual-energy X-ray radiography	Whole-body dual-energy X-ray radiography scan	A week prior to the study baseline
Secondary	Novel Pedar	Mechanosensitive shoe inserts for measurement of ground reaction force	During two one-hour bouts of the exercise intervention