Effects of continuous exercise on time spent in euglycemia and inflammation under the treatment of insulin degludec in patients with type 1 diabetes
- Conditions
- Diabetes mellitus Type 1Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2017-000922-37-AT
- Lead Sponsor
- Medical University of Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
1) Type 1 Diabetes
2) Aged: 18 – 65 years (both inclusive)
3) A1c 7 - 9% (53 – 75 mmol.mol-1) (both inclusive)
4) Fasting c-peptide < 0.25 nmol.l-1 [21]
5) Intensified insulin therapy
6) Diabetes diagnosed > 12 months
7) BMI 18.5 – 27 kg/m2 (both inclusive)
8) more 150 min per week exercising with moderate intensity or more than 75 min per week exercising with high intensity
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Diabetic long-term complications
2) Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
3) Illness or disease, that confound the study results
4) Interference with insulin action
5) Suspected allergy to trial products
6) Addiction to alcohol
7) Use of drugs
8) Mental incapacity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method