Effects of TCM on Beta-cell Function and Insulin Resistance in High Risk Chinese Individuals for T2D (TCM_PDiab_P01)

NCT04441216 | Unknown

• 1 other identifier: CRE-2019.601
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 history of gestational diabetes. They will take a 12-week course of formula: a) JinQi JiangTang Fang (JQJT) including Coptidis Rhizoma, Astragali Radix and Lonicerae Japonicae Flos, b) combined the ingredients of JQJT and Ophiopogonis Radix to make up a novel CM, Jin Mai Fang (JM); to evaluate the effectiveness of Chinese Medicine in preventing diabetes in a controlled setting in order to better understand their actions. They will be followed up for another 12 weeks after the treatment to evaluate the improvement in glucose tolerance of the formula.

Conditions

Prediabetic State

Keywords

Prediabetes; Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Between-group differences in glycemic excursion during 75g OGTT as indicated by area under the curve (AUC) plasma glucose concentration during 12-week on-treatment and 12-week off treatment period

  Plasma glucose during 75g OGTT will be measured at baseline, after 12 weeks treatment and 12 weeks of treatment period

  24 weeks

Secondary Outcomes (9)

• Between group differences in insulin resistance (HOMA-IR),as indicated by area under the curve (AUC) plasma insulin during 12-week on-treatment and 12-week off treatment period

  24 weeks

• Between group differences in beta-cell function (HOMA-beta) as indicated by area under the curve (AUC) plasma insulin during 12-week on-treatment and 12-week off treatment period

  24 weeks

• Between group differences in quantitative insulin sensitivity check index (QUICKI) as indicated by during 12-week on-treatment and 12-week off treatment period

  24 weeks

• Between group differences in insulinogenic index as indicated by during 12-week on-treatment and 12-week off treatment period

  24 weeks

• Between group differences in vital sign during 12-week on-treatment and 12-week off treatment period

  24 weeks

Study Arms (4)

Consultation only

NO INTERVENTION

Review by Chinese Medicine practitioner only

JinQi JiangTang Fang

ACTIVE COMPARATOR

JinQi JiangTang Fang (Rhizoma Coptidis, Radix Astragali and Flos Lonicerae)

Other: Rhizoma Coptidis, Radix Astragali and Flos Lonicerae

JM-ELD

ACTIVE COMPARATOR

JQJT plus extra low dose Ophiopogonis Radix

Other: Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix

JM-LD

ACTIVE COMPARATOR

JQJT plus low doses Ophiopogonis Radix

Other: Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix

Interventions

Rhizoma Coptidis, Radix Astragali and Flos Lonicerae OTHER

granule

JinQi JiangTang Fang

Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix OTHER

granule

JM-ELD; JM-LD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Interventions

Coptidis rhizoma extract; Huang Qi; lonicerae flos

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: June 22, 2020
• Study Start: August 2, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

HK (1)