Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects

NCT03151837 | Completed

• 1 other identifier: CS16148
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects with type 2 diabetes. A total of 40 subjects who meet the inclusion criteria and give written consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Major enrollment criteria include: (1)Subjects have confirmed type 2 diabetes and fail to reach the treatment goal (fasting glucose 140-270mg/dL and hemoglobin A1c (HbA1c) 7-10%) after stable use of 1-3 oral hypoglycemic drugs for 3 months; (2)Subjects have stable diabetes mellitus (DM) history with fasting glucose 140-270mg/dL and HbA1c 7-10% and refuse to use oral medications. Efficacy outcomes include the changes in fasting glucose, Hb1Ac, and insulin sensitivity, and safety assessments include liver and kidney function, and complains made by subjects after the initiation of the investigational products (IP).

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Bitter melon(Momordica charantia); Insulin sensitivity

Outcome Measures

Primary Outcomes (4)

• Fasting glucose

  Fasting glucose in milligram per deciliter

  from baseline at 3 month

• Glycated hemoglobin

  Glycated hemoglobin in percentage

  from baseline at 3 month

• Fasting insulin

  Fasting insulin in milliunit per milliliter

  from baseline at 3 month

• Oral Glucose Tolerance Test

  Oral Glucose Tolerance Test in milligram per deciliter

  from baseline at 3 month

Secondary Outcomes (17)

• Total cholesterol

  from baseline at 3 month

• L.D.L.cholesterol

  from baseline at 3 month

• H.D.L.cholesterol

  from baseline at 3 month

• Body mass index(BMI)

  from baseline at 3 month

• Body fat

  from baseline at 3 month

Study Arms (2)

Momordica charantia

EXPERIMENTAL

Subjects will take the capsule of Greenyn Momordica charantia extracts 600 mg/day orally for three months.

Dietary Supplement: Greenyn Momordica charantia extracts

Placebo control

PLACEBO COMPARATOR

Subjects will take the capsule of Placebo 600 mg/day orally for three months.

Dietary Supplement: Placebo control

Interventions

Greenyn Momordica charantia extracts DIETARY_SUPPLEMENT

Extracts from Momordica charantia containing Momordica charantia insulin receptor binding protein (mcIRBP)

Momordica charantia

Placebo control DIETARY_SUPPLEMENT

Starch

Placebo control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age
• Newly diagnosis with type 2 diabetes based on a fasting plasma glucose(FPG)\>=126 mg/dL or 2-5 postprandial glucose levels during 75-g OGTT\>=200 mg/dL
• The person who take 1-3 or more medicine to treat hyperglycemic but not very effective.(Fasting glucose:140-270mg/dL，HbA1c 7-10%)

You may not qualify if:

• Serum creatinine \> 1.8mg/dL
• Serum ALT, AST, total bilirubin or alkaline phosphatase higher than 2.5 times of the upper normal range
• Anemia (Hb Male: \< 11g/dL;Female: \< 10g/dL)
• Pregnancy or Lactation
• Severe angina
• Moderate-severe heart failure with left ventricular hypertrophy
• BMI\<18 or \>38
• a body weight variation more than 10% during the screening period.
• Dietary habits change in one months or body weight change \>10%
• Life expectancy is low than 6 months
• be allergy to bitter melon
• Severe long-term diabetic complications such as diabetic retinopathy,diabetic neuropathy,systemic orthostatic hypotension,urinary retention,foot ulcers or gastric stasis
• Acute disease
• Participation in another clinical trial within 30 days of screening

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Chien-Ning Huang, Ph.D.

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 12, 2017
• Study Start: May 10, 2017
• Primary Completion: December 16, 2017
• Study Completion: December 16, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)