Trial record 1 of 418 for:    diabetes type 2 AND (woman OR women OR female)
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An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00982371
First received: September 21, 2009
Last updated: June 17, 2012
Last verified: June 2012
  Purpose

The number of people with type 2 diabetes is growing. This puts a lot of pressure on the health care systems. Type 2 diabetes is often associated with health problems, like poor eyesight, muscle coordination, muscle strength, and blood flow. Poor bone health may also be a concern for people with type 2 diabetes.

A large proportion of people with type 2 diabetes will break a bone in their lifetime. The risk of this happening in older people with type 2 diabetes is greater than the risk in older people without diabetes. Fracturing a bone can be very painful, and lead to serious consequences, especially if the individual experiences a hip fracture. The elevated fracture risk, seen in those with type 2 diabetes, is puzzling because people with type 2 diabetes often appear to have normal, healthy bones compared to people of the same age without diabetes.

Bone micro-structure, which is not assessed by traditional bone densitometry systems (ie: DXA) contributes to overall bone strength.

The hypothesis of this study is that bone micro-structure is of poorer quality (reduced trabecular thickness, increased trabecular spacing) in postmenopausal women with type 2 diabetes, compared to age-matched control participants.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Cross-sectional Comparison of Bone Micro-architecture in Postmenopausal Women With Type 2 Diabetes and Age-matched Controls

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 1 Tesla peripheral MRI assessment at non dominant distal radius: Trabecular bone micro-architecture parameters Tb.Th, Tb.Sp, Tb.N, BV/TV, bone CSA, marrow space [ Time Frame: MRI scan complete approximately 1 month after participant is enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Calcium, vitamin D and vitamin K dietary intakes; TUG (sec); grip strength; DXA assessment of hip, lumbar spine, total body; physical activity [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
female; >65 years old; BMI >25kg/m2; postmenopausal >5 yrs; NO clinical diagnosis of type 2 diabetes for >5 years (according to Canadian Diabetes Association criteria)
Type 2 Diabetes
female; >65 years old; BMI >25kg/m2; postmenopausal >5 yrs; clinical diagnosis of type 2 diabetes for >5 years (according to Canadian Diabetes Association criteria)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

female; >65 years old; BMI >25kg/m2; postmenopausal >5 yrs

Criteria

Inclusion Criteria:

  • female
  • >= 65 years old
  • postmenopausal for > 5 years (WHO definition of menopause)

Exclusion Criteria:

  • currently taking osteoporosis related medication (HRT, SERM, bisphosphonate, PTH, calcitonin, fluoride)
  • had cancer in past 10 years, likely to metastasize to bone (ie: breast, lung)
  • have intrinsic bone disease (ie: Paget's Disease, Cushings syndrome)
  • have untreated malabsorption syndrome (ie: Celiac Disease)
  • renal insufficiency (CrCl <30ml/min)
  • hyperparathyroidism, hypoparathyroidism
  • chronic systemic glucocorticosteroid use > 3mos, dose>2.5mg daily
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982371

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
McMaster University
  More Information

Additional Information:
No publications provided

Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT00982371     History of Changes
Other Study ID Numbers: REB 08-281
Study First Received: September 21, 2009
Last Updated: June 17, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
type 2 diabetes mellitus
osteoporosis
bone quality
magnetic resonance imaging
fracture
postmenopausal women >65 years old

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014