Microarchitecture, Bone Strength and Fracture Risk in Long-term Type 1 Diabetes

NCT03751839 | Completed

• 1 other identifier: EKNZ 2018-01517
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

This single center case control study will assess differences in bone structure between women and men with longstanding type 1 diabetes (diabetes duration\>/= 25 years) and healthy controls.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• volumetric bone mineral density in mg hydroxyapatite (HA)/ccm

  measured by HR-pQCT at the distal radius and tibia

  through study completion, an average of 6 months

• cortical porosity in %

  measured by HR-pQCT at the distal radius and tibia

  through study completion, an average of 6 months

• bone stiffness in kilonewton (kN)/mm

  a measure of bone strength, measured by HR-pQCT at the distal radius and tibia

  through study completion, an average of 6 months

• failure load in kN

  a measure of bone strength, measured by HR-pQCT at the distal radius and tibia

  through study completion, an average of 6 months

Secondary Outcomes (18)

• areal bone mineral density of the spine in g/cm2

  through study completion, an average of 6 months

• areal bone mineral density of the proximal femur in g/cm2

  through study completion, an average of 6 months

• areal bone mineral density of the distal radius in g/cm2

  through study completion, an average of 6 months

• trabecular bone score of the spine

  through study completion, an average of 6 months

• cortical thickness at the mid tibia in cm

  through study completion, an average of 6 months

Study Arms (1)

Diagnostic

EXPERIMENTAL

The investigators will examine all participants in the same way by performing biochemical tests, clinical tests, osteodensitometry, HRQCT and HRpQCT measurements.

Diagnostic Test: Biochemical Tests; Diagnostic Test: Osteodensitometry; Diagnostic Test: Clinical Tests; Diagnostic Test: HR-QCT; Diagnostic Test: HR-pQCT

Interventions

Biochemical Tests DIAGNOSTIC_TEST

The investigators will perform blood tests in every participant.

Diagnostic

Osteodensitometry DIAGNOSTIC_TEST

The investigators will perform an osteodensitometry in every participant.

Also known as: dual energy x-ray absorptiometry (DXA scan)

Diagnostic

Clinical Tests DIAGNOSTIC_TEST

The investigators perform the following clinical tests: vibration threshold test, monofilament test, chair rise test and timed up and go test in every participant.

Diagnostic

HR-QCT DIAGNOSTIC_TEST

The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant.

Diagnostic

HR-pQCT DIAGNOSTIC_TEST

The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant.

Diagnostic

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women and men with longstanding type 1 diabetes (age 40-80 years, BMI 18-37 kg/m2 and age- and sex matched non-diabetic controls
• presence of type 1 diabetes for at least 25 years (defined by history of Insulin treatment)

You may not qualify if:

• Patients unable to give written informed consent, e.g. with severe dementia or patients not understanding German (or other local language)
• Any medical or psychiatric condition which would preclude the participant from adhering to the protocol
• Idiopathic or premenopausal osteoporosis or coexisting metabolic bone disease (e.g. Paget´s disease, primary hyperparathyroidism)
• Previous treatment with osteoporosis medication (bisphosphonates, denosumab) or intake of medications that are known to affect bone metabolism (e.g. steroids, anticonvulsants) within 6 months prior to enrollment
• Patients with medical conditions known to affect bone health ( e.g. metastatic bone disease, celiac disease, inflammatory bone disease, hypogonadism, thyrotoxicosis, hypercortisolism, chronic kidney disease stage IV and V (KDIGO), liver dysfunction (serum aspartate amino transferase (ASAT) \>3 times the upper limit of normal)
• Inability to keep the extremities still for a few minutes of an HR-pQCT examination (e.g. Parkinson disease, spastic syndrome)
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Christian Meier: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital Schleswig-Holstein: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Christian Meier, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Christian Meier

Model Details: Identical diagnostic procedures will be performed in participants with type 1 diabetes and age- and sex-matched controls.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 23, 2018
• Study Start: October 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)