Effect of BGG on Glucose Metabolism and Other Markers of Metabolic Syndrome (Glucogold)
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|ClinicalTrials.gov Identifier: NCT02834078|
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : July 15, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Pre Diabetes||Dietary Supplement: BGG Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of 'Berberine Glucogold' [BGG] on Glucose Metabolism in Individuals With Marginally Impaired Glucose Metabolism Along With Other Markers of Metabolic Syndrome|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Dose: 01 tablet three times daily just before all major meals (breakfast, lunch and dinner)
Dietary Supplement: BGG
Placebo Comparator: Placebo
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)
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834078
|Principal Investigator:||Sandip Patil, M.D.||Maharashtra Council of Indian Medicine|
|Principal Investigator:||Rajesh Kewalramani, M.B.B.S.||Maharashtra Council of Indian Medicine|