Clinical trial NCT04093856: Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes
Official title: Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: CHU de Quebec-Universite Laval
First posted: 2019-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: Muscle size measured as cross-sectional muscle area at the proximal femur
timeFrame: Baseline
measure: Muscle composition measured as muscle fat content at the proximal femur
timeFrame: Baseline
measure: Volumetric bone mineral density (vBMD) at the spine, hip, radius and tibia
timeFrame: Baseline
Secondary outcomes:
measure: N-terminal propeptide of type 1 procollagen concentration
timeFrame: Baseline
measure: Osteocalcin (total and decarboxylated) concentration
timeFrame: Baseline
measure: Bone specific alkaline phosphatase concentration
timeFrame: Baseline
measure: C-telopeptide concentration
timeFrame: Baseline
measure: Fasting glucose concentration
timeFrame: Baseline
measure: Fasting Hemoglobin A1c concentration
timeFrame: Baseline
measure: Insulin concentration
timeFrame: Baseline
measure: Serum 25-hydroxyvitamin D concentration
timeFrame: Baseline
measure: Parathormone concentration
timeFrame: Baseline
measure: Estradiol concentration
timeFrame: Baseline
measure: Insulin like growth factor-1 concentration
timeFrame: Baseline
measure: Sclerostin concentration
timeFrame: Baseline
measure: Adiponectin concentration
timeFrame: Baseline
measure: Leptin concentration
timeFrame: Baseline
measure: Body composition measured as visceral and subcutaneous adipose tissue
timeFrame: Baseline
measure: Body composition measured by fat and lean mass
timeFrame: Baseline
measure: Bone marrow adiposity
timeFrame: Baseline
measure: Upper extremity muscle strength measured by grip force in kg
timeFrame: Baseline
measure: Lower extremity muscle strength measured by peak torque generated by knee extension
timeFrame: Baseline
measure: Functional mobility measured by time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
timeFrame: Baseline
measure: Functional exercise capacity measured by total distance ambulated during a 6 minute time period
timeFrame: Baseline
measure: Self-reported physical activity measured in metabolic equivalents (MET)
timeFrame: Baseline
measure: Cutaneous Advanced glycation end products (AGEs) measurement
timeFrame: Baseline
measure: Physical activity measured by total activity and time spent in different intensities of exercise measured over 7 consecutive days
timeFrame: Baseline
measure: Functional balance score obtained using multidimensional balance assessment. Higher scores indicate better balance abilities
timeFrame: Baseline
measure: Physical health
timeFrame: Baseline
measure: Community Participation Restriction
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: Baseline
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: Centre de recherche de l'IUCPQ
Study officials:
References: