Effects of continuous exercise on time spent in euglycemia and inflammation under the treatment of insulin degludec in patients with type 1 diabetes

Effects of continuous exercise on time spent in euglycemia and inflammation under the treatment of insulin degludec in patients with type 1 diabetes – a crossover, randomized trial (InflamEx)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000922-37-AT

Enrollment

Registered

2017-04-27

Start date

2017-06-09

Completion date

Unknown

Last updated

2024-03-12

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

Conditions

Diabetes mellitus Type 1

Interventions

Trade Name: Tresiba Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN DEGLUDEC CAS Number: 844439-96-9 Concentration unit: U/ml unit(s)/millilitre Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Difference in mean time in euglycemia 24 hours after exercise;Secondary Objective: DiffInflammation: Difference in IL-6 in comparison over time within the group/between groups ? FGMacc: Accuracy of interstitial glucose compared to blood glucose from 0 to 45 min during CE. ? BGdeltalowex: Blood glucose decrease during exercise to lowest glucose concentration from 0 to 45 min ? BGmeanex: Mean blood glucose from 0 to 45 min during exercise ? BG45minex: Blood glucose concentration after 45 min of exercise ? BGdeltaex: Difference in blood glucose concentration from immediate pre-exercise until 45 minutes of exercise ? BGmin: Minimum blood glucose concentration during exercise from 0 to 45 min ? Hypoex: Numbers of confirmed hypoglycemic episodes during exercise (< 4.4 mmol.l-1) ? CHO/INSpostex: Number/amount of carbohydrate and insulin administrations given during exercise from 0 to 45 min in response to hypo- or hyperglycemia;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Main Objective: Difference in mean time in euglycemia 24 hours after exercise;Secondary Objective: DiffInflammation: Difference in IL-6 in comparison over time within the group/between groups ? FGMacc: Accuracy of interstitial glucose compared to blood glucose from 0 to 45 min during CE. ? BGdeltalowex: Blood glucose decrease during exercise to lowest glucose concentration from 0 to 45 min ? BGmeanex: Mean blood glucose from 0 to 45 min during exercise ? BG45minex: Blood glucose concentration after 45 min of exercise ? BGdeltaex: Difference in blood glucose concentration from immediate pre-exercise until 45 minutes of exercise ? BGmin: Minimum blood glucose concentration during exercise from 0 to 45 min ? Hypoex: Numbers of confirmed hypoglycemic episodes during exercise (< 4.4 mmol.l-1) ? CHO/INSpostex: Number/amount of carbohydrate and insulin administrations given during exercise from 0 to 45 min in response to hypo- or hyperglycemia;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria

Contacts

Public ContactDep. Endocrinology and Diabetology

Medical University of Graz

ha.sourij@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026