Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT04093856
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2019-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes
Sponsor:
Suzanne Morin
Organization:
Study Overview
Official Title:
Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BODI2
Brief Summary:
Background: Osteoporotic fractures are a major public health issue. They cause substantial disability, loss of autonomy, morbidity and excess mortality. Diabetes is also associated with increased risk for falls and fractures through a direct impact of elevated blood glucose on the skeleton and on muscles.
Research project overview: The investigators propose a cross-sectional study that will involve 2 research centers in the province of Quebec. The investigators will recruit 20 obese participants, without diabetes, who have not undergone bariatric surgery, for one-time measurements to be compared with baseline measurements (pre-surgery) from participants in the bariatric obese diabetic groups with type II diabetes mellitus from the ongoing study BODI study (NCT03455868). Bone Mineral Density as well as muscle quality, strength and function will be evaluated at a single study visit.
Relevance: This data will permit the evaluation of the bone-muscle unit in patients with obesity with and without diabetes, and assess whether the presence and duration of diabetes impacts further on clinical and functional musculoskeletal outcomes (falls, fractures and mobility and strength) in this population. AGEs, if associated with muscle and bone deterioration, might become an easily accessible biomarker of musculoskeletal health in the clinical setting.
Research project overview: The investigators propose a cross-sectional study that will involve 2 research centers in the province of Quebec. The investigators will recruit 20 obese participants, without diabetes, who have not undergone bariatric surgery, for one-time measurements to be compared with baseline measurements (pre-surgery) from participants in the bariatric obese diabetic groups with type II diabetes mellitus from the ongoing study BODI study (NCT03455868). Bone Mineral Density as well as muscle quality, strength and function will be evaluated at a single study visit.
Relevance: This data will permit the evaluation of the bone-muscle unit in patients with obesity with and without diabetes, and assess whether the presence and duration of diabetes impacts further on clinical and functional musculoskeletal outcomes (falls, fractures and mobility and strength) in this population. AGEs, if associated with muscle and bone deterioration, might become an easily accessible biomarker of musculoskeletal health in the clinical setting.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: