An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes

NCT00982371 | Completed DMC

• 1 other identifier: REB 08-281
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus; osteoporosis; bone quality; magnetic resonance imaging; fracture; postmenopausal women >65 years old

Outcome Measures

Primary Outcomes (1)

• 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

  MRI scan complete approximately 1 month after participant is enrolled

Secondary Outcomes (1)

• Calcium, vitamin D and vitamin K dietary intakes; TUG (sec); grip strength; DXA assessment of hip, lumbar spine, total body; physical activity

  baseline

Study Arms (2)

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 Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• McMaster University: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

CA (1)