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A real-world study of blood glucose fluctuation in newly diagnosed overweight type 2 diabetes mellitus by Qingre Lishi decoction

A real-world study of blood glucose fluctuation in newly diagnosed overweight type 2 diabetes mellitus by Qingre Lishi decoction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080912
Enrollment
Unknown
Registered
2024-02-18
Start date
2023-12-01
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

type 2 diabetes

Interventions

Sponsors

the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? According to the T2DM criteria defined in the Guideline for the Prevention and Treatment of Type 2 diabetes mellitus in China (2020 edition); ? According to the syndrome of Damp-heat trapping the spleen in the Guidelines for Integrated Diagnosis and Treatment of Type 2 Diabetes Mellitus (2020 Edition) and the Guidelines for Clinical Diagnosis and Treatment of Diabetes Mellitus in Traditional Chinese Medicine (2020 Edition); ? The course of the disease is = 12 months; ? The age of patients were between 18 and 65, regardless of gender; ? Overweight and obese, BMI = 24kg/m2, defined by Chinese criteria29; ?no COVID-19 infections in the last 6 months, 48 hours negative for novel coronavirus-N gene test and negative for novel coronavirus-ORF1ab gene test.

Exclusion criteria

Exclusion criteria: ? Failure to meet the new diagnosis of T2DM; ? Women who are pregnant or breastfeeding; ? Those with severe heart, lung, brain, liver and kidney diseases; ? Combination of any diabetic comorbidities and complications of diabetes mellitus; ? Allergy or intolerance to therapeutic drugs; ? Severe mental disorders, hysteria and inability to communicate properly; ? Other diseases that may have an effect on glucose metabolism; ? Experience of a critical illness or other stressful situation within the last month; ? Participation in other studies within the last 3 months; ? COVID-19 infection in the last 6 months, or 48 hours positive for novel coronavirus-N gene and positive for novel coronavirus-ORF1ab gene.

Design outcomes

Primary

MeasureTime frame
fasting blood glucose;2-hour postprandial blood glucose;glycated hemoglobin;standard deviation of blood glucose;mean amplitude of glycemic excursions;maximum blood glucose fluctuation amplitude;average absolute difference of daytime blood glucose;coefficient of variation;time in range of blood glucose;time above range of blood glucose;time below range of blood glucose;

Secondary

MeasureTime frame
Body Mass Index;triglyceride;Low density lipoprotein cholesterol;fasting C-peptide;liver function;renal function;

Countries

China

Contacts

Public ContactTianshu Gao

the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

gaotianshu67@163.com+86 24 8296 1190

Outcome results

None listed

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