MedPath

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

Phase 2
Recruiting
Conditions
type 2 diabetes
Registration Number
ITMCTR2024000006
Lead Sponsor
the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
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

(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.

Study & Design

Study Type
Observational study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
low density lipoprotein;liver function;renal function;triglyceride;fasting C-peptide;Body Mass Index;
© Copyright 2025. All Rights Reserved by MedPath