E11
Conditions
Interventions
Group 1: This study aims to investigate the acute effect of a 30-minute constant velocity treadmill walking protocol on the inflammatory response to a high-carbohydrate meal in individuals with type 2
Sponsors
Universität Bayreuth
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: - Informed consent obtained. - Male or female aged 18–85 years (both inclusive). - Clinically diagnosed with type 2 diabetes mellitus. - HbA1c =6,5 and =9,5 %. - Body mass index <40 kg·m-2.
Exclusion criteria
Exclusion criteria: - Simultaneous enrolment in any other study. - Known or suspected hypersensitivity to trial products or related products. - Receipt of any investigational medicinal product within 1 week prior to screening in this trial. - Suffering from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influence the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and not adapted throughout the run of the trial. Furthermore, it does not excluded patients who have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific diet, e.g. gluten-free. - Heart rate <35 beats per minute after resting for 5 min in supine position at screening. - Blood pressure outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic after resting for 5 min in supine position at screening (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives. - Significant abnormal ECG at screening, as judged by the medical investigator. - Any chronic (metabolic) disorder other than type 2 diabetes mellitus or severe disease which, in the opinion of the investigator, might jeopardize the participant’s safety or compliance with the protocol. - History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. - History of alcoholism or drug abuse. Participant with mental incapacity or language barriers including adequate understanding or cooperation or who, in the opinion of their general practitioner or the investigator, should not participate in the trial. - Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator. - Females of childbearing potential who intend to become pregnant or are pregnant, or are not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner). This also includes females who are breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interleukin-6?: Change in interleukin-6 (IL6) levels (?pg·mL-1) between t0 and t180 in comparison of the four trial arms (FAT-Ex, FAT-Rest, CHO-Ex, CHO-Rest). | — |
Secondary
| Measure | Time frame |
|---|---|
| Interleukin-8?: Change in interleukin-8 (IL8) levels (?pg·mL-1) between t0 and t180 in comparison of the four trial arms (FAT-Ex, FAT-Rest, CHO-Ex, CHO-Rest). | — |
Countries
Germany
Contacts
Public ContactOthmar Moser
Universität Bayreuth
Outcome results
None listed