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SteepRamp validation & tendon structure in DM2.

Validating the SteepRamp test for estimating physical fitness and an AGE test to predict tendinopathy structure in type 2 diabetes.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28345
Enrollment
165
Registered
2010-02-11
Start date
2010-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Diabetes Mellitus type 2

Interventions

Physical exercise has a prominent role in the treatment of type 2 diabetes mellitus (DM2). This research project aims to improve exercise intervention programs in DM2 by validating a novel easy applic

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam Afdeling Revalidatie geneeskunde / Sportgeneeskunde Intern adres: Kamer H. 026 postbus 2040 3000 CA Rotterdam Nederland
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Substudy A: 1. Type 2 diabetes mellitus >2 yr; 2. Age: 30-80 years; 3. BMI: 27-40 kg/m2; 4. 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. 1. Type 2 diabetes mellitus >2 yr; 2. Age: 35-60 years, (15 male, 15 female); 3. Formal permission to participate in the study by signing an informed consent form. 30 controls will be matched for gender and age.

Exclusion criteria

Exclusion criteria: Substudy A and B: 1. Cardiovascular disease such as heart failure, cardiac ischemia or serious peripheral vascular disease (e.g. claudicatio intermittens); 2. Serious orthopedic of neurological conditions precluding an exercise test or muscle strength test. Substudy B: 1. Use of fluoroquinolones.

Design outcomes

Primary

MeasureTime frame
Substudy A: Validating the supramaximal SteepRamp exercise test to determine physical fitness in type 2 diabetes patients by correlating the result with a conventional VO2max exercise test and determining the test-retest reliability. Substudy B: Comparing Achilles tendinosis incidence in type 2 diabetes patients with the incidence in matched controls.

Secondary

MeasureTime frame
Substudy A: 1. Develop a regression formula to predict VO2max, daily activity pattern and quadriceps strength from SteepRamp test results in type 2 diabetes patients; 2. Obtaining reference values for physical fitness, activity pattern en quadriceps strength for type 2 diabetes patients; 3. Correlating physical fitness with the level of AGE in type 2 diabetes patients. Substudy B: 1. Correlating muscle strength and activity pattern with Achilles tendon structure abnormalities in type 2 diabetes patients; 2. Correlating advanced glycation end-products (AGE) with Achilles tendon structure abnormalities in type 2 diabetes patients.

Contacts

Public ContactD. Visser

P.O. box 2040

d.visser.1@erasmusmc.nl+31 (0)10 7031679

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)