Status:
COMPLETED
Effects of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes
Lead Sponsor:
Chulalongkorn University
Conditions:
Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
A 12-week, open-label, randomized, controlled trial investigating effect of mulberry leaves plus lifestyle intervention on glycemic control compare with lifestyle intervention alone in patients with o...
Detailed Description
Diabetes remains a common leading cause of morbidity and mortality among population worldwide over decades. Obesity, a crucial risk factors for developing T2DM, commonly exists with insulin resistance...
Eligibility Criteria
Inclusion
- Women or men age 20-65 years
- Have 1 of 3 characteristics as follows;
- Non-diabetic obese patients (BMI ≥25 kg/m2)
- Patients with T2DM: drug naïve and newly diagnosed within 6 months before study enrollment
- Patients with T2DM: inadequate control (A1c ≥7%, but not \>8%) with metformin therapy (\>1,000 mg/day) alone at least 3 months before study enrollment
- Well communicate in the Thai language
Exclusion
- Allergy to mulberry leaves products
- FPG ≥180 mg/dL
- A1c \>8%
- AST and ALT \>40 U/L
- Cr \<0.6 or \>1.2 mg/dL
- BUN \>20 mg/dL
- Existing or having history of gastrointestinal surgery or abnormal conditions affecting digestion and intestinal absorption
- Existing or having history of hematological disorders, thyroid diseases, CVD, ischemic stroke, CKD, or other uncontrolled and life-threatening conditions
- Presence of significant diabetic complications
- Taking drugs, supplements, and herbs affecting blood glucose level: corticosteroids, second-generation antipsychotics, niacin, thiazide diuretics, and ß-blockers, within 1 month before study enrollment
- Taking unnecessary drugs, supplements, and herbs affecting lipid level within 1 month before study enrollment
- Women during pregnancy or lactation
Key Trial Info
Start Date :
May 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04691219
Start Date
May 26 2019
End Date
February 19 2020
Last Update
December 31 2020
Active Locations (1)
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1
Pornanong Aramwit
Bangkok, Thailand, 10330