An Alternative Approach to Improve Hyperglycemia Among Type 2 Diabetes Patients

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Dietary Supplement: Bitter melon juice (100 ml); Behavioral: Exercise

• Registration Number: NCT04268212
• Lead Sponsor: Arizona State University

Brief Summary

The study compared the effect of bitter melon intake and moderate exercise on postprandial glucose levels as measured by incremental area under the curve (iAUC) in eight patients with type 2 diabetes.

Detailed Description

Background: This study compared the effects of bitter melon intake and moderate-intensity physical activity on postprandial glucose responses in type 2 diabetic patients.

Methods: A total of 8 patients with type 2 diabetes were randomly assigned to two sequences (AB, BA) with two treatments (A or B) using a 2 x 2 randomized cross-over design: A) 100 ml of bitter melon juice administered 15 minutes prior to the 75-g oral glucose load; B) 30 minutes walking at moderate-intensity performed 15 minutes after the oral glucose load.

Study Timeline

• Study Start: 2016-04-15
• Primary Completion: 2016-08-20
• Study Completion: 2016-09-20
• Status Verified: 2020-02
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• An age of 20 to 79 years
• Physician-diagnosed type 2 diabetes
• Medical clearance for physical activity from their healthcare provider

Exclusion Criteria

• Pregnant or were receiving insulin treatment
• An allergy to bitter melon
• Medical conditions that impacted the normal the functioning of the gastrointestinal tract
• Contraindications to physical activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bitter Melon	Bitter melon juice (100 ml)	The participants were asked to consume 100 ml of bitter melon juice 15 minutes prior to the 75-g oral glucose intake. Participants drank the juice within 5 minutes. Participants remained seated throughout the following 2 hours.
Exercise	Exercise	Participants performed 30 minutes of treadmill walking at 65% of the age-predicted maximum heart rate. The exercise started 15 minutes after the 75-g oral glucose intake.

Primary Outcome Measures

Name	Time	Method
incremental area under the curve	2-hour postprandial period	2-hour postprandial glucose incremental area under the curve
mean glucose	2-hour postprandial period	mean glucose values