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

Recruiting

• Conditions: Diabetes mellitus; 10018424; 10043237

• Registration Number: NL-OMON38192
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 225

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

Substudy A and B
• Cardiovascular disease: objectived heart failure (ejection fraction <35%),
electrocardiographically objectived cardiac ischemia or symptomatical peripheral
vascular disease objectived by Doppler ultrasound investigation
• Serious orthopedic of neurological conditions precluding an exercise test or muscle
strength test;Substudy B
• Use of fluoroquinolones

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Substudy A<br /><br>• The VO2max measured during a maximal RAMP exercise test.<br /><br>• The maximal workload in watts during a supra-maximal SteepRamp exercise test.<br /><br><br /><br>Substudy B<br /><br>• Result of the UTC measurement.</p><br>

Secondary Outcome Measures

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