Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes

NCT ID: NCT04093856

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2021-06-14

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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity; Body Weight; Bone Diseases, Metabolic; Fractures, Bone; Osteoporotic Fractures; Osteoporosis; Quality of Life; Fall; Musculoskeletal Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Diabetic

20 men and women with type 2 diabetes and obesity

No interventions assigned to this group

Non-diabetic

20 normoglycemic men and women with obesity matched for age and sex with diabetic group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

A) Diabetic group

• BMI >=35 kg/m2
• Clinical diagnosis of type 2 diabetes
• Use of oral hypoglycemic agents or insulin or 2 of the following tests confirming type 2 diabetes: HbA1c >=6.5%; fasting glucose >=7.0 mM; 2-h glucose post 75g oral glucose tolerance test (OGTT) >=11.1 mM)

B) Non-diabetic group:

• BMI >=35 kg/m2
• Normoglycemia (HgbA1c <5.7% and Fasting glucose <5.6 nM)

Exclusion Criteria

• BMI >60 kg/m2
• Clinical diagnosis of type 1 diabetes
• Disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance <60 ml/min)
• Medication (e.g. gluccocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism
• Pregnancy
• History of oesophageal, gastric, digestive or bariatric surgery
• Prosthesis that could interfere with interpretation of imaging data
• Chronic severe condition or illness precluding from participation in the project.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: collaborator

Suzanne Morin

OTHER

Sponsor Role: lead

Responsible Party

Suzanne Morin

Clinician Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada

Centre de recherche de l'IUCPQ

Québec, , Canada

Countries

Canada

Other Identifiers

MP-37-2020-5872

Identifier Type: -

Identifier Source: org_study_id