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

NCT04093856 | Completed

• 1 other identifier: MP-37-2020-5872
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

Advanced glycation end products; Advanced imaging; Mobility; Strength

Outcome Measures

Primary Outcomes (3)

• Muscle size measured as cross-sectional muscle area at the proximal femur

  Measured by quantitative computed tomography (QCT)

  Baseline

• Muscle composition measured as muscle fat content at the proximal femur

  Measured by quantitative computed tomography (QCT)

  Baseline

• Volumetric bone mineral density (vBMD) at the spine, hip, radius and tibia

  Measured by quantitative computed tomography (QCT)

  Baseline

Secondary Outcomes (28)

• N-terminal propeptide of type 1 procollagen concentration

  Baseline

• Osteocalcin (total and decarboxylated) concentration

  Baseline

• Bone specific alkaline phosphatase concentration

  Baseline

• C-telopeptide concentration

  Baseline

• Fasting glucose concentration

  Baseline

Study Arms (2)

Diabetic

20 men and women with type 2 diabetes and obesity

Non-diabetic

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is a multi-center, cross-sectional, observational study comprising of two groups of participants with obesity either with or without diabetes (n=20/group). The diabetic groups will include 20 adult men and women with obesity and type 2 diabetes, and the non-diabetic group will consist of 20 age- and sex- matched individuals with obesity and normoglycemia.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzanne Morin: lead
• CHU de Quebec-Universite Laval: collaborator

Study Sites (2)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

Location

Centre de recherche de l'IUCPQ

Québec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinician Researcher

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 18, 2019
• Study Start: January 14, 2020
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)