Status:
UNKNOWN
Effects of TCM on Beta-cell Function and Insulin Resistance in High Risk Chinese Individuals for T2D (TCM_PDiab_P01)
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Prediabetic State
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study involves prediabetes volunteers who are at high risk of developing diabetes, including those with family history of diabetes, metabolic syndrome, fatty liver, polycystic ovary syndrome and ...
Detailed Description
In China, 10% of adults have diabetes and 30% of people have prediabetes. In Hong Kong, 2 in 100 adults develop pre-diabetes every year and in 2014, 9% of adults have prediabetes. People with prediabe...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Individuals aged ≥18 years-70 years
- BMI≥18 kg/m2
- Chinese ethnicity
- Individuals with pre-diabetes based on 75 gram oral glucose tolerance test (OGTT) defined as impaired fasting glycemia (fasting plasma glucose (FPG): ≥5.6-6.9 mmol/L) and/or impaired glucose tolerance (IGT) (2-h PG: ≥7.8-11.0 mmol/L) -
- Plus at least one risk factor(s) from the following list:
- 2 components of the metabolic syndrome
- Triglyceride≥1.7 mmol/L
- BP≥130/80 mmHg
- HDL-C\<1.3 mmol/L in women or \<1.1 mmol/L in men
- Waist circumference≥80 cm in women or ≥90 cm in men
- Fatty liver
- Diagnosis by ultrasound scan and/or
- Diagnosis by fibroscan and/or
- Diagnosis by ALT\>35 IU/L in men and \>24 IU/L in women
- History of diabetes in first degree relatives
- History of gestational diabetes mellitus
- History of polycystic ovary syndrome
- Exclusion criteria
- Not willing to participate in this study or adhere to study procedures
- Significant medical history including but not limited to history of CVD, renal estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 and/or liver dysfunction (AST and/or ALT≥3 times upper limit of normal)
- History of drug abuse or excessive alcohol intake based on investigator judgment
- Dehydration, diarrhea or vomiting at the time of recruitment
- Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment
- Subjects with blood haemoglobin outside the normal range (male: 13.5-17.5 g/dl and female: 12-15.5 g/dl)
- Subjects who have donated blood in the 3 months prior to the study and/or plan to donate blood during the study period
- Current use of dietary supplements or health products affecting glycose or galactose metabolism or body weight in previous 1 month before first dosing.
- Breast feeding, pregnant women or women with plans for pregnancy
- Any conditions considered unsuitable by the investigators
- Subjects with use of Warfarin
- Subjects with known G6PD deficiency or known history of herb-drug interactions
- Known history of diabetes mellitus and/or HbA1c \>= 6.5%.
- Usage of glucose lowering drugs and/or weight loss drugs currently or within 1 month before first dosing
- Previous metabolic surgery
- Known history of thyroid disorders
Exclusion
Key Trial Info
Start Date :
August 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04441216
Start Date
August 2 2020
End Date
June 1 2023
Last Update
July 20 2022
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong