Type2 DiabetesNCT04268212
An Alternative Approach to Improve Hyperglycemia Among Type 2 Diabetes Patients
A study testing Bitter melon juice (100 ml) and Exercise in people with Type2 Diabetes, run by Arizona State University.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Bitter melon juice (100 ml) and Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2016to 20 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An age of 20 to 79 years
- Physician-diagnosed type 2 diabetes
- Medical clearance for physical activity from their healthcare provider
Who cannot join
- 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
About this study
Official title: Effects of Bitter Melon Intake and Moderate-Intensity Physical Activity on Postprandial Glucose Responses in Type 2 Diabetic 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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- Bitter melon juice (100 ml), Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean glucose
mean glucose values
Measured: 2-hour postprandial period
incremental area under the curve
2-hour postprandial glucose incremental area under the curve
Measured: 2-hour postprandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start15 Apr 2016
- Primary completion20 Aug 2016
- Study completion20 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chong Lee, Ph.D., Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268212
- Sponsor's protocol ID
- STUDY00004172
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bitter Melon Intake and Moderate-Intensity Physical Activity on Postprandial Glucose Responses in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04268212
- Acronym / sponsor ID
- STUDY00004172
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 20 Aug 2016 (actual)
- Study completion
- 20 Sep 2016 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bitter Melon | Experimental | Dietary Supplement: 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 | Experimental | Behavioral: ExerciseParticipants 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. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- An age of 20 to 79 years
- Physician-diagnosed type 2 diabetes
- Medical clearance for physical activity from their healthcare provider
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Bitter Melon |
| ExerciseThe 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. | Behavioural | Exercise |
Primary outcome
mean glucose
Time frame: 2-hour postprandial period
mean glucose values
incremental area under the curve
Time frame: 2-hour postprandial period
2-hour postprandial glucose incremental area under the curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chong Lee, Ph.D. principal investigator
Arizona State University
Questions about this trial
What is this clinical trial studying?
A study testing Bitter melon juice (100 ml) and Exercise in people with Type2 Diabetes, run by Arizona State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean glucose (time frame: 2-hour postprandial period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.