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Completed

NCT Number: NCT04268212

An Alternative Approach to Improve Hyperglycemia Among Type 2 Diabetes Patients

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.

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Key information

Conditions

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bitter melon juice (100 ml)

Dietary Supplement

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.

Exercise

Behavioral

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.

Primary outcomes

  1. mean glucose

    Time frame: 2-hour postprandial period

    mean glucose values

  2. incremental area under the curve

    Time frame: 2-hour postprandial period

    2-hour postprandial glucose incremental area under the curve

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 13, 2020
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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