Type 2 DiabetesPhase 2/3NCT00499148
Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
A Phase 2/3 study testing herbal extract; root of woody shrub grown in India/Sri-Lanka in people with Type 2 Diabetes, run by Abbott Nutrition at 2 sites in United States.
Trial summary
The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- herbal extract; root of woody shrub grown in India/Sri-Lanka
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Oct 2007
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- Between 18 and 75 years of age
- Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
- If of childbearing potential, is practicing birth control
- BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
- If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit
Who cannot join
- Uses insulin for glucose control or has type 1 diabetes
- History of diabetic ketoacidosis.
- Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
- Active malignancy
- Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
- End state organ failure or status post organ transplant
Show all 13Show fewer
- History of renal disease
- Current hepatic disease
- History of severe gastroparesis
- Has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
- Currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
- Clotting or bleeding disorders
- Allergic or intolerant to any ingredient found in the study products
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Radiant Research
Cincinnati, Ohio, 45249
Radiant Research
Edina, Minnesota, 55435
About this study
Official title: Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.
- Conditions
- Type 2 Diabetes
- Being tested
- herbal extract; root of woody shrub grown in India/Sri-Lanka
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herbal extract; root of woody shrub grown in India/Sri-LankaOther
What is being measured
The primary outcome is the main question the study is designed to answer.
positive AUC for plasma glucose
Measured: 4 hours
Secondary outcomes (1)
positive AUC for serum insulin; adjusted peak values for plasma glucose and serum insulin; baseline plasma glucose and serum insulin concentrations; adjusted values for plasma glucose and serum insulin at individual postprandial time points.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startAug 2006
- Primary completionAug 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jennifer A. Williams, MPH, Study director, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499148
- Sponsor's protocol ID
- BJ82
- Status last verified
- Apr 2009
- First submitted
- 5 Jul 2007
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00499148
- Acronym / sponsor ID
- BJ82
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Jul 2007 (estimated)
- 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 purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- type 2 diabetes
- Between 18 and 75 years of age
- Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
- If of childbearing potential, is practicing birth control
- BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
Key exclusion criteria (13 listed)
- Uses insulin for glucose control or has type 1 diabetes
- History of diabetic ketoacidosis.
- Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
- Active malignancy
- Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
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 |
|---|---|---|
| herbal extract; root of woody shrub grown in India/Sri-Lanka | Other | – |
Primary outcome
positive AUC for plasma glucose
Time frame: 4 hours
1 secondary outcome
positive AUC for serum insulin; adjusted peak values for plasma glucose and serum insulin; baseline plasma glucose and serum insulin concentrations; adjusted values for plasma glucose and serum insulin at individual postprandial time points.
Time frame: 4 hours
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 30 Jul 2010.
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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.
Jennifer A. Williams, MPH study director
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing herbal extract; root of woody shrub grown in India/Sri-Lanka in people with Type 2 Diabetes, run by Abbott Nutrition at 2 sites in United States.
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 6 inclusion and 13 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 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
positive AUC for plasma glucose (time frame: 4 hours). 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 30 Jul 2010.