Bone structure characteristics and non-coding RNA profiles in people with diabetes mellitus: the RBoneCT- Study

Recruiting

• Conditions: E10; E11; Type 1 diabetes mellitus; Type 2 diabetes mellitus

• Registration Number: DRKS00022762
• Lead Sponsor: Medizinische Universität Graz, Klinische Abteilung für Endokrinologie und Stoffwechsel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Group I: Subjects with type 1 diabetes and previous low-energy fracture (T1withF), =18 years, established diabetes mellitus type 1 (>1 year) treated with insulin therapy, previous history of low-energy bone fracture/s, 25-hydroxyvitamin D =20 ng/ml achieved with or without Vitamin D supplementation;

Group II: Subjects with type 1 diabetes without previous low-energy fracture (T1withoutF), Age=18 years, established diabetes mellitus type 1 (>1 year) treated with insulin therapy, 25-hydroxyvitamin D =20 ng/ml achieved with or without Vitamin D supplementation;

Group III: Subjects with type 2 diabetes and previous low-energy fractures (T2withF), Age =18 years, established diabetes mellitus type 2 (>1 year) treated with any glucose lowering therapy except pioglitazone, previous history of low-energy bone fracture/s, 25 (OH) Vitamin D =20 ng/ml achieved with or without Vitamin D supplementation;

Group IV: Subjects with type 2 diabetes without previous low-energy fractures (T2withF), Age =18 years, established diabetes mellitus type 2 (>1 year) treated with any glucose lowering therapy except pioglitazone, 25 (OH) Vitamin D =20 ng/ml achieved with or without Vitamin D supplementation;

Exclusion Criteria

Group I: osteoanabolic therapy, antiresorptive bone therapy;
Group II: previous low-energy fractures and/or osteoprotective therapy;
Group III: osteoanabolic therapy, antiresorptive bone therapy;
Group IV: previous low-energy fractures and/or osteoprotective therapy;

General exclusion criteria which apply for all of the aforementioned groups: 25 (OH) Vitamin D <20 ng/ml, severe abnormalities in thyroidal or gonadal function evaluated at the discretion of the study investigators, BMI >40 kg/m2, pregnancy, severe renal impairment (estimated glomerular filtration <30 ml/min/1.73 m²) or current hemodialysis, medication with negative impact on bone (steroids, anabolics, pioglitazone etc.), secondary disorders of bone or mineral metabolism (Primary hyperparathyreoidism, Paget´s disease, osteogenesis imperfecta, osteomalacia), metallic implants on the non-dominant arm or both lower legs.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective is the difference in body mass density between participants with type 1 and type 2 diabetes considering the presence or absence of a previous low-energy fracture and to compare bone mass density and structure assessed by HR-pQCT and DXA in individuals with type 1 diabetes and type 2 diabetes with and without previous low-energy fractures.

Secondary Outcome Measures

Name	Time	Method
To compare ncRNA profiles in those with type 1 diabetes and type 2 diabetes with or without previous low-energy fractures.