An Alternative Approach to Improve Hyperglycemia Among Type 2 Diabetes Patients

Type2 Diabetes Clinical Trial

Official title:

Effects of Bitter Melon Intake and Moderate-Intensity Physical Activity on Postprandial Glucose Responses in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268212
• Other study ID #: STUDY00004172
• Status: Completed
• Phase: N/A
• Start date: April 15, 2016
• Est. completion date: September 20, 2016

Study information

• Verified date: February 2020
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 20, 2016
• Est. primary completion date: August 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Dietary Supplement:
• Bitter melon juice (100 ml)
Fresh bitter melon fruits were purchased from certified local groceries. The seeds of bitter melon were removed, and the juice was obtained from the raw fruit using a blender. Every 140 g of bitter melon fruit produced approximately 100 ml bitter melon juice.

Behavioral:
• Exercise
The walking exercise was started 15 minutes after the glucose load. Walking speed was determined to elicit 65% of the maximum heart rate (HRmax) during exercise for each participant. HRmax was estimated using the America College of Cardiology prediction model, HRmax=208 - 0.7 × age. All participants wore a heart rate monitor (Polar, Vantage, XL) around the chest to assess exercise intensity. A rate of perceived exertion was assessed every 2 minutes based on the Borg's scale.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean glucose	mean glucose values	2-hour postprandial period
Primary	incremental area under the curve	2-hour postprandial glucose incremental area under the curve	2-hour postprandial period