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Feasibility, Safety, and Effectiveness of Chinese Herbal Medicine for T2DM Patients With Comorbid Metabolic Syndrome: A Single-arm Pilot Study
This is a single-arm design. A total of 15 Type 2 Diabetes Mellitus (T2DM) patients with comorbid Metabolic Syndrome (MetS) will be recruited from community. The intervention will be a 4-week of Chinese Herbal Medicine granules treatment, which will consist of six Chinese herbs. The primary outcome measure will be fasting plasma glucose and blood pressure. Secondary outcome measures including changes of anthropometric data (body mass index, waist-to-hip ratio), lipid panels (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), HbA1C, Framingham Stroke Risk Score (FSRS), Audit of diabetes-dependent quality of Life (ADDQoL), International Physical Activity Questionnaire Short Form (IPAQ-SF), daily step count and physiological parameters from wearable watch, dietary record, retinal and sublingual vein imaging, concurrent medications and adverse events.
Details
| Lead sponsor | Hong Kong Baptist University |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 15 |
| Start date | 2024-06 |
| Completion | 2024-10 |
Conditions
- Type 2 Diabetes Mellitus With Metabolic Syndrome
Interventions
- Chinese Herbal Medicine granules
Primary outcomes
- Fasting plasma glucose (FPG) — Baseline, week 2, week 4, week 8.
FPG will be determined by taking a blood sample from participants who have fasted for 8-12 hours. - Blood pressure — Baseline, week 2, week 4, week 8.
Blood pressure was measured thrice, after a 10 min rest, using a standard digital sphygmomanometer.