Effects of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Mulberry leaves powder; Behavioral: Diet control

• Registration Number: NCT04691219
• Lead Sponsor: Chulalongkorn University

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 obesity and patients with type 2 diabetes (T2DM)

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 and impaired beta-cell function. Early management in individuals at high risk of T2DM should be therefore considered for preventing or delaying the progression of diabetes and diabetic complications.

Since 1-deoxynojirimycin (DNJ), the major antihyperglycemic compound of mulberry leaves, inhibits alpha-glucosidase activities, ingestion of mulberry leaves results in the suppression of postprandial hyperglycemia. Long-term effects of mulberry leaves on glycemic profiles have been demonstrated in numerous clinical studies; however, the results were controversial. In addition, no study was conducted in patients with obesity. As a result, this open-label, randomized controlled study aims to investigate efficacy and safety of mulberry leaves in combination with lifestyle intervention (diet control) on glycemic control in non-diabetic patients with obesity and patients with early-stage T2DM. Efficacy of the interventions will be assessed based on the changes in glycemic indexes, expression of proteins related to insulin resistance and T2DM, and lipid profiles. Meanwhile, safety will be measured by the changes in renal and hepatic enzymes and patient-self reports. The outcomes will be monitored at 4-week interval throughout 12 weeks of the study period.

Study Timeline

• Study First Submitted: 2018-03-06
• Study Start: 2019-05-26
• Primary Completion: 2020-02-19
• Study Completion: 2020-02-19
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-29
• Last Update Submitted: 2020-12-29
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Women or men age 20-65 years

2. 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

3. Well communicate in the Thai language

Exclusion Criteria

1. Allergy to mulberry leaves products
2. FPG ≥180 mg/dL
3. A1c >8%
4. AST and ALT >40 U/L
5. Cr <0.6 or >1.2 mg/dL
6. BUN >20 mg/dL
7. Existing or having history of gastrointestinal surgery or abnormal conditions affecting digestion and intestinal absorption
8. Existing or having history of hematological disorders, thyroid diseases, CVD, ischemic stroke, CKD, or other uncontrolled and life-threatening conditions
9. Presence of significant diabetic complications
10. 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
11. Taking unnecessary drugs, supplements, and herbs affecting lipid level within 1 month before study enrollment
12. Women during pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mulberry leaves powder plus diet control	Diet control	-
Diet control alone	Diet control	-
Mulberry leaves powder plus diet control	Mulberry leaves powder	-

Primary Outcome Measures

Name	Time	Method
Effect on 2-hour postprandial glucose (PPG) during 75-g oral glucose tolerance test (OGTT) (efficacy)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of the 2-hour PPG (in mg/dL) during 75-g OGTT at week 12
Effect on fasting plasma glucose (FPG) (efficacy)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of FPG (in mg/dL) at week 4, 8, and 12
Effect on glycated hemoglobin (A1C) (efficacy)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of A1C (in %) at week 12

Secondary Outcome Measures

Name	Time	Method
Effect on triglycerides (efficacy)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of triglycerides (in mg/dL) at week 12
Effect on total cholesterol (efficacy)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of total cholesterol (in mg/dL) at week 12
Effect on high-density lipoprotein cholesterol (HDL-C) (efficacy)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of HDL-C (in mg/dL) at week 12
Effect on insulin resistance index (efficacy)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of Homeostasis model assessment indexes of insulin resistance (HOMA-IR) at week 12
Adverse effects on renal function (safety)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of serum creatinine (in mg/dL) at week 12
Effect on low-density lipoprotein cholesterol (LDL-C) (efficacy)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of LDL-C (in mg/dL) at week 12
Adverse effects on hepatic function 1 (safety)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of aspartate aminotransferase (AST) (in units/L) at week 12
Adverse effects on hepatic function 2 (safety)	12 weeks	To evaluate difference between the treatment group and the control group, and change from baseline of alanine aminotransferase (ALT) (in units/L) at week 12
Self-reported adverse events (safety)	12 weeks	Participants in the treatment group (those who were assigned to administer mulberry leaves) were asked to report adverse events caused by mulberry leaves administration (i.e. constipation, diarrhea, abdominal cramp, bloating, and hypoglycemia) to the researchers.

Trial Locations

Locations (1)

Pornanong Aramwit; 🇹🇭 Bangkok, Thailand