Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT01870557
Eligibility Criteria:
Inclusion Criteria:
* Type 1 or type 2 diabetes.
* Age ≥ 50 years.
* Unaltered treatment of diabetes during the previous six months (no changes in drugs, but an increase or decrease in dose is accepted) and HbA1c is stable with a level of ± 1 in the same period.
* HbA1c level≥ 7 % through the previous six months.
* BMI between 19 og 35.
Specific inclusion criteria for type 2 diabetes:
* Either treatment with metformin, sulfonylureas, dipeptidyl peptidase IV (DPP IV) inhibitors or glucagon-like peptide 1 (GLP-1) analogs.
* Treatment with insulin and insulin in the combination with metformin, sulfonylureas, DPP IV inhibitors or GLP-1 analogs.
Exclusion Criteria:
* HbA1C \> 10%
* Pregnancy.
* Metal implanted at both ankles and wrists.
* Patients treated with: Antiresorptive (incl. hormone replacement therapy) or bone anabolic treatment, glucocorticoids, lithium and anticonvulsives.
* Patients with a bone disease other than osteoporosis.
* Vertebral fracture visible by vertebral fracture assessment (VFA).
* Patients with renal disease defined by estimated glomerular filtration rate(eGFR) \< 50.
* Other medical disease in unstable phase (fx. cancer, hyperthyroidism).
* Heart failure; New York Heart Association (NYHA) class IV.
* Patients which the investigator does not believe is fit to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01870557
Study Brief:
Protocol Section:
NCT01870557