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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
Phase 2
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2024000006
Enrollment
Unknown
Registered
2024-01-15
Start date
2023-12-01
Completion date
Unknown
Last updated
2024-01-22

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: (1)Damp-Heat-Spleen-Distressing T2DM that meets established criteria; (2)the course of the disease is = 12 months; (3)the age of patients were between 18 and 65, regardless of gender; (4)overweight and obese, BMI = 24kg/m2, defined by Chinese criteria29;.

Exclusion criteria

Exclusion criteria: (1)failure to meet the new diagnosis of T2DM;(2)women who are pregnant or breastfeeding;(3)those with severe heart, lung, brain, liver and kidney diseases;(4)combination of any diabetic comorbidities and complications of diabetes mellitus; (5)allergy or intolerance to therapeutic drugs;(6)severe mental disorders, hysteria and inability to communicate properly;(7)other diseases that may have an effect on glucose metabolism;(8)experience of a critical illness or other stressful situation within the last month;(9) participation in other studies within the last 3 months; (10)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
coefficient of variation;standard deviation;mean of daily differences;mean amplitude of glycemic excursions;time in range;fasting blood glucose;time above range;time below range;large amplitude of glycemic excursions;glycated hemoglobin;2-hour postprandial blood glucose;

Secondary

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

Countries

China

Contacts

Public ContactTianshu Gao

the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

gaotianshu67@163.com024-82961989

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 5, 2026