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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT06783218
Eligibility Criteria:
Inclusion Criteria (T2D group):
* Women and men between the ages of 30 and 70.
* Meet any criteria diagnosis of prediabetes or type 2 diabetes according to the American Diabetes Association (ADA), without pharmacological treatment for glycaemic control.
* Excess weight, according to body mass index (BMI) value \> 25 kg/m2.
* Body fat percentage, measured by bioelectrical impedance analysis (BIA), above the normal range, according to age and sex, following the classification from Gallagher D, et al. Am J Clin Nutr. 2000;72(3):694-701.
Inclusion Criteria (Healthy group):
* Women and men between the ages of 30 and 70.
* No impaired glucose metabolism according to ADA diagnostic criteria
* Normal weight, according to BMI value (18,5 - 24,9 kg/m2)
* Body fat percentage, measured by BIA, within the normal range, according to age and sex, following the classification from Gallagher D, et al. Am J Clin Nutr. 2000;72(3):694-701.
Exclusion Criteria:
* Chronotype within the categories "extreme evening" (\<34) or "extreme morning" (\>76), according to the Hörne-Orberg Morning-Evening Questionnaire (MEQ) classification.
* Weight changes (± 4.5 kg) during the last 3 months.
* Habitually consuming ≥ 14 units of alcohol/week in women and ≥ 21 units of alcohol/week in men.
* Self-reported use of drugs of abuse in the last 12 months.
* Be an active smoker or have quit smoking within the last 3 months.
* Night or late shift work (finishing later than 11 pm on a permanent basis).
* Recent travel across 2 or more time zones during the last month before the start of the study.
* Show poor cooperation or, in the opinion of the investigator, have difficulty following the study procedures.
* In the case of women, being pregnant or breastfeeding .
* Blood donation in the 3 months prior to the beginning of the study.
Medical conditions:
* Oral diseases, inflammation or lesions at the time of the study.
* Any clinical condition, including chronic metabolic diseases, systemic intestinal, hepatic or renal diseases, when the research team consider that it may influence the results of the study.
* Severe hyperlipidaemia, severe hypertension or hypothyroidism, untreated or treated for less than 3 months with stable dose.
* Have relevant functional or structural abnormalities of the digestive tract, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory diseases or malabsorption.
* Subjects who have undergone surgery of the digestive tract with permanent sequelae, including surgical treatment for obesity.
* Any type of psychological/psychiatric impairment such as depressive pathology, anxiety or bipolar disorder, when the research team consider that it may influence the results of the study.
* Any type of cancer or be undergoing treatment for it, or that a period of at least 5 years has not elapsed since its eradication.
* A diagnosed eating disorder (such as bulimia or binge eating disorder)
* Presence of any type of health problem that may affect sleep
* Any infection at the time of the study, especially respiratory or intestinal infection.
Medication:
* Be under continuous pharmacological/hormonal treatment that may affect glycaemic control.
* Current or within the previous 2 months use of prescription or non-prescription medication or nutritional supplements that have the potential to affect glycaemic control, as well as biochemical analyses. For food supplements containing biotin, they are permitted provided that their consumption is omitted 48 h before blood draws.
* Current or within the previous 2 months use of nutritional supplements or prescription or non-prescription drugs that may affect the microbiota (probiotics, prebiotics, fibre, antibiotics, antifungals).
* Taking any medication that may seriously affect circadian rhythms (melatonin receptor agonist drugs (tasimelteon, ramelteon), drugs for the treatment of drowsiness (modafinil, armodafinil), or with sedative effects (benzodiazepines, zolpidem)) or nutritional supplements that contain melatonin and are likely to affect circadian rhythms, except if on a stable dose for 3 months or more.
* Cholesterol-lowering medication, except if on a stable dose for 3 months or more.
* Blood pressure lowering medication, unless on a stable dose for 3 months or more.
* Medication that may affect appetite and body weight (e.g. antidepressants, thyroid) unless on a stable dose for 3 months or more and without significant side effects.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT06783218
Study Brief:
Protocol Section:
NCT06783218