Effect of exercise on the acute inflammatory response to a high carbohydrate and high fat meal in individuals with type 2 diabetes.A randomized controlled trial - ExFlam

niversität Bayreuth0 sites11 target enrollmentSeptember 27, 2023

ConditionsE11 Type 2 diabetes mellitus

Overview

Phase: 未知
Intervention: Not specified
Conditions: E11
Sponsor: niversität Bayreuth
Enrollment: 11
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 27, 2023

End Date

August 11, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversität Bayreuth

Eligibility 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

•\- 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.