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:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT02358668
Eligibility Criteria:
Inclusion Criteria:
1. Adult subjects ≥ 18-70 years inclusive
2. Chinese ethnicity
3. High risk subject with pre-diabetes as defined by meeting at least 2 of the following criteria from (a), (b) and (c):
1. FPG ≥ 5.6-6.9 mmol/l and/or 2-hour PG ≥ 7.8-11.0 mmol/l during 75 gram OGTT
2. HbA1c ≥ 5.7-6.4%
3. At least one of the following risk factors:-
* History of gestational diabetes
* Family history of diabetes in first degree relative
* 2 components or more of the metabolic syndrome (triglyceride ≥ 1.7 mmol/L, blood pressure (BP) ≥ 130/80 mmHg, high density-lipoprotein (HDL) cholesterol \<1.3 mmol/L in women or \<1.1 in men and waist circumference ≥ 80 cm in women or ≥ 90 cm in men). Patients on anti-hypertensive agent for treatment of hypertension or lipid lowering drug for the treatment of hyperlipidaemia will respectively be considered to have one component of the metabolic syndrome.
4. Subject is capable of giving informed consent prior to the initiation of any study related procedures
5. A female subject of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate and effective contraception to avoid pregnancy during the study period and up to 30 days after the final visit.
6. The subject is able and willing to consistently record food diary to facilitate CGMS evaluation.
Exclusion Criteria:
1. Subject has received anti-diabetic agents within 6 weeks prior to screening visit.
2. On dietary supplement known to affect glucose or galactose metabolism.
3. History of acute cardiovascular disease including myocardial infarction, acute coronary syndrome or stroke which required hospitalization in the last 12 months.
4. Significant renal impairment with estimated glomerular filtration rate (eGFR) \< 60ml/min/1.73m2
5. Known lactose or galactose intolerance.
6. History of eating disorder.
7. Pregnant or lactating female subjects.
8. Subjects with gastrointestinal disease that may interfere with absorption of the investigational product.
9. Subject has received any investigational product within 30 days of randomization visit.
10. Reduced life expectancy or any condition considered by the investigator as unsuitable for enrolment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02358668
Study Brief:
Protocol Section:
NCT02358668