DRKS00032569CompletedUnknown
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 enrollmentStarted: September 27, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 11
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (—)
- Sex
- All
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.
- •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.
Investigators
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