Pre DiabetesGlucogoldNCT02834078
Effect of BGG on Glucose Metabolism and Other Markers of Metabolic Syndrome
A study testing BGG in people with Pre Diabetes, run by Vedic Lifesciences Pvt. Ltd..
Trial summary
According to the International Diabetes Federation, one in every 12 individuals is a diabetic (about 8% of the world population). Major risk factors of diabetes are all the aspects of modern life which include obesity, over-weight, high-risk behavior like smoking, alcohol, multiple drug use-recreational or prescribed… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- BGG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able and willing to provide informed consent.
- Treatment naïve male-female aged 20-60 years of age.
- BMI ≥ 25 kg/m²
- Oral glucose tolerance test (OGTT) ≥140 and ≤250 mg/dl (pre-diabetes and early diagnosed diabetes within 45 days of diagnosis)
- Patient with chronic stable illness can be included ONLY IF he/she is currently NOT on any of the medications included in prohibited list of medicines.
- Currently on herbal supplements can be included after a wash-out period of 7 days.
- Subjects willing to abstain from nicotine and alcohol in the duration of the study.
Who cannot join
- Subjects with OGTT<140 mg/dl or ≥ 250 mg/dl
- Current treatment with diabetes medications, including metformin
- Current treatment with glucocorticoids
- History of clinically significant hematological, hepatic or renal diseases, as per investigator discretion
- Uncontrolled chronic disease
- Hormonal Disorders
Show all 15Show fewer
- Subjects on Steroids
- Subjects on Statins
- Chronic inflammatory diseases requiring any medication
- Migraine, Sinusitis
- Subjects Consuming NSAIDS for long term
- Medications include the drugs of prohibited range.
- Pregnant and lactating females.
- Subjects addicted to nicotine, alcohol or any other recreational drug.
- Subjects who are planning to fast for more than 4 days/ per month during the study.
About this study
Official title: Effect of 'Berberine Glucogold' [BGG] on Glucose Metabolism in Individuals With Marginally Impaired Glucose Metabolism Along With Other Markers of Metabolic Syndrome
According to the International Diabetes Federation, one in every 12 individuals is a diabetic (about 8% of the world population). Major risk factors of diabetes are all the aspects of modern life which include obesity, over-weight, high-risk behavior like smoking, alcohol, multiple drug use-recreational or prescribed, environmental risk factors like inactivity and lack of exercise. However there is a window of opportunity between health and disease, which is pre-diabetes.
Pre-diabetes has been defined by American Diabetes Association as Impaired Glucose Tolerance (IGT) which is 7.8 -11.0 mmol/l, Impaired Fasting Glucose Test (IFT) which is 5.6-6.9mmol/l and now added Glycosylated Hemoglobin (HbA1c) of 5.7% to 6.4%.
Read more
Though there are plenty of drugs available for significantly impaired glucose metabolism (including oral hypoglycemic agents and insulin), their use in marginally impaired glucose metabolism is questionable due to risk of untoward hypoglycemia.
On the other hand, herbal products like curcumin, as a single ingredient has poor bioavailability problem that restricts its use as standalone treatment. Inulin works as pre-biotic and help to maintain gut microbiota which is considered as precursor for progress of prediabetes to diabetes. However, it does not have any role in primary pathophysiology of impaired glucose metabolism, i.e. pancreatic β cell dysfunction, insulin resistance, hepatic gluconeogenesis or intestinal glucose absorption. Resveratrol and omega-3 basically work on anti-oxidant pathways.
None of these popular ingredients has been studied for their role in structural and functional health of pancreatic β cells which is very important for prediction of further progress of marginally impaired glucose metabolism to significantly impaired glucose metabolism.
It is an unmet need to develop a product which not only improves insulin sensitivity, but also help to preserve the structural and functional health of pancreatic β cells. It also needs to improve overall metabolic and endothelial health of the person considering the close association between impaired glucose metabolism and these parameters.
The proposed supplement - "Berberine GlucoGold "- is an improved version of successfully marketed supplement - Berberine GlucoDefense. It has a balanced composition in which all the ingredients complement each other in such a way that along with the individual role in glucose metabolism it also takes care of overall bioavailability and stability of the supplement. As per the previous data on ingredients, the supplement is also expected to preserve the structural and functional health of pancreatic β cells. The ingredients are also known to have positive effect on overall metabolic and endothelial health. Thus BGG has been developed to address the unmet needs in the area of glucose metabolism and overall metabolic health.
- Conditions
- Pre Diabetes
- Being tested
- BGG, Placebo
- Keywords
- HbA1c, Pre Diabetes, Berberine
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGGDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| BGG | Experimental | Dose: 01 tablet three times daily just before all major meals (breakfast, lunch and dinner) Receives: Dietary Supplement: BGG |
| Placebo | Placebo comparator | Matching placebo capsules [for BGG tablet] composed of micro crystalline cellulose and added colors and odors. Dose: 01 tablet three times daily just before all major meals (breakfast, lunch and dinner) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Disposition Index
Measured: Day 0, Day 28, Day 56 and Day 84
Change in Glycated hemoglobin
Measured: Day 0, Day 28, Day 56 and Day 84
Secondary outcomes (2)
Change in Fasting blood sugar
Measured: Day 0, Day 28, Day 56 and Day 84
Change in Body Mass Index
Measured: Day 0, Day 28, Day 56 and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Healthy Directions, LLC
- Responsible party
- Sponsor
- Investigators
- Sandip Patil, M.D., Principal investigator, Maharashtra Council of Indian MedicineRajesh Kewalramani, M.B.B.S., Principal investigator, Maharashtra Council of Indian Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834078
- Sponsor's protocol ID
- HD/150301/BGG/PD
- Acronym
- Glucogold
- Status last verified
- Jul 2016
- First submitted
- 6 Jul 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 'Berberine Glucogold' [BGG] on Glucose Metabolism in Individuals With Marginally Impaired Glucose Metabolism Along With Other Markers of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02834078
- Acronym / sponsor ID
- Glucogold / HD/150301/BGG/PD
- Conditions
- Pre Diabetes
- Keywords
- HbA1c, Pre Diabetes, Berberine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Healthy Directions, LLC
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Jul 2016 (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.
According to the International Diabetes Federation, one in every 12 individuals is a diabetic (about 8% of the world population). Major risk factors of diabetes are all the aspects of modern life which include obesity, over-weight, high-risk behavior like smoking, alcohol, multiple drug use-recreational or prescribed, environmental risk factors like inactivity and lack of exercise. However there is a window of opportunity between health and disease, which is pre-diabetes.
Pre-diabetes has been defined by American Diabetes Association as Impaired Glucose Tolerance (IGT) which is 7.8 -11.0 mmol/l, Impaired Fasting Glucose Test (IFT) which is 5.6-6.9mmol/l and now added Glycosylated Hemoglobin (HbA1c) of 5.7% to 6.4%.
Though there are plenty of drugs available for significantly impaired glucose metabolism (including oral hypoglycemic agents and insulin), their use in marginally impaired glucose metabolism is questionable due to risk of untoward hypoglycemia.
On the other hand, herbal products like curcumin, as a single ingredient has poor bioavailability problem that restricts its use as standalone treatment. Inulin works as pre-biotic and help to maintain gut microbiota which is considered as precursor for progress of prediabetes to diabetes. However, it does not have any role in primary pathophysiology of impaired glucose metabolism, i.e. pancreatic β cell dysfunction, insulin resistance, hepatic gluconeogenesis or intestinal glucose absorption. Resveratrol and omega-3 basically work on anti-oxidant pathways.
None of these popular ingredients has been studied for their role in structural and functional health of pancreatic β cells which is very important for prediction of further progress of marginally impaired glucose metabolism to significantly impaired glucose metabolism.
It is an unmet need to develop a product which not only improves insulin sensitivity, but also help to preserve the structural and functional health of pancreatic β cells. It also needs to improve overall metabolic and endothelial health of the person considering the close association between impaired glucose metabolism and these parameters.
The proposed supplement - "Berberine GlucoGold "- is an improved version of successfully marketed supplement - Berberine GlucoDefense. It has a balanced composition in which all the ingredients complement each other in such a way that along with the individual role in glucose metabolism it also takes care of overall bioavailability and stability of the supplement. As per the previous data on ingredients, the supplement is also expected to preserve the structural and functional health of pancreatic β cells. The ingredients are also known to have positive effect on overall metabolic and endothelial health. Thus BGG has been developed to address the unmet needs in the area of glucose metabolism and overall metabolic health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGG | Experimental | Dietary Supplement: BGGDose: 01 tablet three times daily just before all major meals (breakfast, lunch and dinner) |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo capsules [for BGG tablet] composed of micro crystalline cellulose and added colors and odors. Dose: 01 tablet three times daily just before all major meals (breakfast, lunch and dinner) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able and willing to provide informed consent.
- Treatment naïve male-female aged 20-60 years of age.
- BMI ≥ 25 kg/m²
- Oral glucose tolerance test (OGTT) ≥140 and ≤250 mg/dl (pre-diabetes and early diagnosed diabetes within 45 days of diagnosis)
- Patient with chronic stable illness can be included ONLY IF he/she is currently NOT on any of the medications included in prohibited list of medicines.
Key exclusion criteria (15 listed)
- Subjects with OGTT<140 mg/dl or ≥ 250 mg/dl
- Current treatment with diabetes medications, including metformin
- Current treatment with glucocorticoids
- History of clinically significant hematological, hepatic or renal diseases, as per investigator discretion
- Uncontrolled chronic disease
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 |
|---|---|---|
| BGG | Dietary supplement | BGG |
| Placebo | Other | Placebo |
Primary outcome
Change in Oral Disposition Index
Time frame: Day 0, Day 28, Day 56 and Day 84
Change in Glycated hemoglobin
Time frame: Day 0, Day 28, Day 56 and Day 84
2 secondary outcomes
Change in Fasting blood sugar
Time frame: Day 0, Day 28, Day 56 and Day 84
Change in Body Mass Index
Time frame: Day 0, Day 28, Day 56 and Day 84
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 15 Jul 2016.
- 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.
Sandip Patil, M.D. principal investigator
Maharashtra Council of Indian Medicine
Rajesh Kewalramani, M.B.B.S. principal investigator
Maharashtra Council of Indian Medicine
Questions about this trial
What is this clinical trial studying?
A study testing BGG in people with Pre Diabetes, run by Vedic Lifesciences Pvt. Ltd..
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 7 inclusion and 15 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 15 Jul 2016. 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. Some participants in this study may receive a placebo. 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?
Change in Oral Disposition Index (time frame: Day 0, Day 28, Day 56 and Day 84). 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 15 Jul 2016.