An Alternative Approach to Improve Hyperglycemia Among Type 2 Diabetes Patients

NCT04268212 | Completed

• 1 other identifier: STUDY00004172
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

• mean glucose

  mean glucose values

  2-hour postprandial period

• incremental area under the curve

  2-hour postprandial glucose incremental area under the curve

  2-hour postprandial period

Study Arms (2)

Bitter Melon

EXPERIMENTAL

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.

Dietary Supplement: Bitter melon juice (100 ml)

Exercise

EXPERIMENTAL

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.

Behavioral: Exercise

Interventions

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.

Bitter Melon

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.

Exercise

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chong Lee, Ph.D.

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: April 15, 2016
• Primary Completion: August 20, 2016
• Study Completion: September 20, 2016
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share