Validating the SteepRamp test for estimating the physical fitness and an AGE test to predict tendinopathy structure in diabetes.

Validating the SteepRamp test for estimating the physical fitness and an AGE test to predict tendinopathy structure in diabetes. - SteepRamp validation & tendon structure in DM

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38192

Enrollment

225

Registered

2010-05-10

Start date

2010-05-17

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Substudy A • Type 2 diabetes mellitus • Age: 30-80 years • Formal permission to participate in the study by signing an informed consent form Substudy B 30 cases from substudy A will be included in substudy B • Type 2 diabetes mellitus • Age: 35-60 years, (15 male, 15 female) • Formal permission to participate in the study by signing an informed consent form 30 type 1 diabetes patients • Type 1 diabetes mellitus • Age: 18-30 years, (15 male, 15 female) • Formal permission to participate in the study by signing an informed consent form 60 controls will be matched for gender and age

Exclusion criteria

Exclusion criteria: Substudy A and B • Cardiovascular disease: objectived heart failure (ejection fraction

Design outcomes

Primary

Measure	Time frame
Substudy A • The VO2max measured during a maximal RAMP exercise test. • The maximal workload in watts during a supra-maximal SteepRamp exercise test. Substudy B • Result of the UTC measurement.	—

Secondary

Measure	Time frame
Substudy A • Workload in watts during maximal RAMP exercise test. • Performance on an sub-maximal exercise test (0,5-1-1,5 watt/kg.2 min). • Fat percentage, B.M.I. abdominal circumference. • Isokinetic quadriceps strength. • Time to complete a standardized Sit-to-Stand test. • Estimated kcal expenditure over 7 days based on measurements using a validated multi-sensor accelerometer (Actigraph®). • Hemoglobin, HbA1c, plasma glucose, HDL-C, LDL-C, Total-Cholesterol, triglycerides and free fatty acids (blood) and microalbuminuria (urine). Substudy B • Result of the skin auto-fluorescence test using the AGE-reader®.	—

Measure

Time frame

Substudy A • Workload in watts during maximal RAMP exercise test. • Performance on an sub-maximal exercise test (0,5-1-1,5 watt/kg.2 min). • Fat percentage, B.M.I. abdominal circumference. • Isokinetic quadriceps strength. • Time to complete a standardized Sit-to-Stand test. • Estimated kcal expenditure over 7 days based on measurements using a validated multi-sensor accelerometer (Actigraph®). • Hemoglobin, HbA1c, plasma glucose, HDL-C, LDL-C, Total-Cholesterol, triglycerides and free fatty acids (blood) and microalbuminuria (urine). Substudy B • Result of the skin auto-fluorescence test using the AGE-reader®.

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Countries

Netherlands

Outcome results