Bone Turnover in Type 2 Diabetes and Non-diabetes Controls (DiaMarv)

NCT05585697 | Completed

• 1 other identifier: AUH_HOK_2022_1
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes (T2D) is related to an increased risk of major fractures which does written in English. The summary is used not only increase society health care costs, but also increase the morbidity and in the recruitment of peer reviewers.: mortality for patients with T2D. Traditional fracture predictors underestimate the risk in T2D. Thus, the bone affection is not caused by decreased bone mineral density but rather by impaired bone quality leading to fragile bone. In diabetes, circulating bone turnover markers are suppressed and advanced glycation endproducts may accumulate in the tissue. The study aims at exploring whether bone turnover in T2D is compromised in the circulation, bone marrow, and bone tissue and whether advanced glycation endproducts accumulate in these tissues. Furthermore, the investigators will assess whether bone turnover markers predict fractures in a cohort of individuals with diabetes. The project will contribute to the knowledge on bone disease in T2D and will ultimately benefit the patients by improving future fracture prevention strategies.

Conditions

Diabetes Mellitus, Type 2; Bone Fragile

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of Osteocalcin

  Circulating bone turnover marker

  2 years

Secondary Outcomes (13)

• Plasma concentration of CTX

  2 years

• Plasma concentration of P1NP

  2 years

• Plasma concentration of Sclerostin

  2 years

• Bone marrow serum concentration of P1NP

  2 years

• Bone marrow serum concentration of CTX

  2 years

Study Arms (1)

Type 2 diabetes or control

Individuals with type 2 diabetes. Expect to include 26. Individuals without type 2 diabetes. Expect to include 26.

Other: None - crossectional

Interventions

None - crossectional OTHER

None - crossectional

Type 2 diabetes or control

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

26 individials with type 2 diabetes and 26 controls without type 2 diabetes

You may qualify if:

• physician diagnosed T2D,
• diabetes duration ≥5 years,
• HbA1c ≥ 48 mmol/mol through the last 2 years
• male gender,
• age \> 40 years
• BMI \< 35 kg/m2
• no diagnosis of T2D
• male gender,
• age \> 40 years
• BMI \< 35 kg/m2

You may not qualify if:

• trombocyte count \< 100
• treatment with anticoagulants except acetylic acids,
• renal impairment (eGFR \<50 ml/min),
• bone metabolic disease
• vitamin D insufficiency
• treatment with antiosteoporotic agents
• Treatment with systemic glucocorticoids
• Tetracycline allergy.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, bone marrow and bone tissue

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: October 7, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)