Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT03814694
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes with HbA1c between 48 mmol/mol and 97 mmol/mol with or without metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors
* Overweight or obesity with BMI ≥ 25 kg/m2 and desired weight loss
* Non-smokers for \> 1 year
* Willingness to abstain from alcohol for 6 weeks
* Hemoglobin \> 7 mmol/L for men and \> 6 mmol/L for women
* Estimated glomerular filtration rate (eGFR) \> 30 mL/min/1.73 m2
Exclusion Criteria:
* Critical illness as evaluated by the principal investigator
* Systemic corticosteroid treatment, e.g. prednisolone
* Reported or journalized severe food allergy or intolerance
* Reported or journalized severe gut disease e.g. Crohn's disease, Coeliac disease etc.
* Reported or journalized alcohol dependence syndrome
* Injectable diabetes medication, including insulin and GLP-1 analogues
* Sulfonylureas (SUs) and sodium-glucose cotransporter 2 (SGLT-2) inhibitors, unless discontinuation is possible, in which case a 2-month wash-out is mandatory
* Repeated fasting plasma glucose \> 13.3 mmol/L
* Urine albumin / creatinine ratio \> 300 mg/g
* Lactation, pregnancy or planning of pregnancy during the study
* Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the principal investigator
* Presently participating in other clinical trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03814694
Study Brief:
Protocol Section:
NCT03814694