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A single-center, randomized, controlled study on the reversal of pre-diabetes by Traditional Chinese Medicine fasting therapy

A randomized controlled clinical trail of pre-diabetes reversal by Traditional Chinese Medicine fasting therapy - Pre-diabetes reversal trail

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070215
Enrollment
Unknown
Registered
2023-04-05
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-daibetes

Interventions

Traditional Chinese Medicine fasting therapy (TCM-FT):Traditional Chinese Medicine fasting therapy
Normal lifestyle control (CT):Normal lifestyle intervention

Sponsors

the Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 20-65 years old; 2. Overweight/obesity defined as BMI >= 25 kg/m^2; 3. The heart, liver and kidney functions were normal; 4. Pre-diabetes was diagnosed according to the criteria of Chinese Guidelines for the Prevention and Treatment of type 2 diabetes mellitus 2022 edition. 5. Not history of medication for PDM; 6. Informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant, breastfeeding or menstruating; 2. Abnormal heart, liver and kidney function; 3. Under 20 years of age or over 65 years of age; 4. Patients with malignant tumors and blood diseases; 5. Patients with active pulmonary tuberculosis; 6. Ulcer patients with severe gastric bleeding; 7. Unable to cooperate with treatment, poor compliance; 8. Those who did not sign informed consent; Serious co-morbidities; 9. Glutamic acid decarboxylase antibody (GADA) is positive; 10. Other conditions judge by the investigator to be ineligible for enrollment.

Design outcomes

Primary

MeasureTime frame
Oral glucose tolerance test, OGTT;Islet function;Weight;BMI;

Secondary

MeasureTime frame
waist circumference;hip circumference;lipid profile;liver/pancreas lipid contents;

Countries

China

Contacts

Public ContactZhang Li

the Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)

zhangli53@mail2.sysu.edu.cn+86 156 2649 0129

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026