An interventional study of GlucoSupreme™ Herbal and Placebo in Prediabetic State, sponsored by University of Maryland, Baltimore. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-28.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
Among 390 studies in Prediabetic State with a site in United States — 84 open to participants now, 108 under way, 2 of them phase 3. Prediabetic State · United States.
Among the 390 studies in Prediabetic State with a site in United States, this one is the 218th largest by enrollment of the 362 interventional ones that give a count, is one of 20 that started in 2017, is one of 288 with no phase, and was the 141st registered.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
Browse Prediabetic State studies →84 of the 390 studies in Prediabetic State with a site in United States are open now. Recruiting first, the newest first:
Rahul Sachdeva · Sites in United States
Ages 18+ · Healthy volunteers
University of South Florida · Sites in United States
Ages 18–70
St. Louis University · Sites in United States
Ages 18–69
Morehouse School of Medicine · Sites in United States
Ages 12+ · Healthy volunteers
Penn State University · Sites in United States
Ages 25–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 145 Prediabetic State studies recruiting now, 51 (35%) set no upper age limit and 84 (58%) stop at 75 or younger; 12 take children under 18; 54 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
390 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 25 · Phase 3 16 · Phase 4 16
First in 1996; this study’s year is marked. 20 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 39 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Median enrollment 54 across the 362 interventional studies, 188 across the 28 observational. Of the 257 that completed or were terminated, 89 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
35 of 390 have an industry lead sponsor. The 10 most frequent:
University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 131 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
University of Maryland, Baltimore has 3 studies filed under Prediabetic State — fewer than ten, so there is no comparison to draw.
45 of the studies in Prediabetic State with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06995378University of California, Los AngelesStudy EHR Risk Stratification Tools | 2026-11 |
| NCT05165706Stanford UniversityLongitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance | 2026-11-30 |
| NCT07450118University of DelawareNested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans | 2026-12 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT07868432Tufts UniversityGlycemic Impact of NNS Via the Gut Microbiome | 2026-12 |
Add all 45 to your calendar (.ics) → With an account.
Among the 390 studies in Prediabetic State with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary purpose of this study is to evaluate the impact of a polyherbal dietary supplement (Designs for Health - GlucoSupreme™ Herbal) on markers of glycemic control and other structure/function outcomes among a sample of prediabetic adults.
A 12-week randomized, double-blinded, placebo-controlled clinical trial will be conducted to achieve the purpose of this study. The research team hypothesizes that GlucoSupreme™ Herbal will improve a variety of validated markers of glycemic control that are commonly used in clinical practice more effectively than placebo.
Prediabetes is a common state in which blood glucose levels are elevated, but are not elevated high enough to be considered Type 2 Diabetes (T2D). The worldwide prevalence of prediabetes is high and rapidly increasing. People with prediabetes are at increased risk for developing a variety of chronic diseases. Most notably, prediabetes nearly always precedes diagnosis of T2D, a poorly-controlled disease adversely affecting 14% of adults in the United States. T2D is responsible for increased risk of heart disease, stroke, blindness and other vision problems, kidney disease, amputations and death. Prediabetes often progresses to T2D relatively quickly, as pancreatic beta-cell dysfunction perpetuates. There are currently limited pharmacological options available for safely reducing the burden of prediabetes. Furthermore, these pharmacological options often carry potentially deleterious side effects. Low-risk alternatives are needed where lifestyle modifications, such as increased physical activity and weight loss, have failed.
Herbal dietary supplements have shown promise in safely managing impaired glycemic control in prediabetic adults in many clinical studies. A wide variety of herbs have been previously studied for these purposes, including cinnamon, fenugreek, banaba, curcumin, and a variety of combination products. Of these, most have demonstrated improved management of glycemic control, particularly with regard to reducing fasting blood glucose and postprandial glucose, HbA1c, fasting insulin levels, HOMA-Insulin Resistance, and increasing HOMA-β cell function among prediabetic adult populations. Many herbs have also demonstrated benefit in the management of glycemic control in clinical trials among T2D populations. These herbs include berberine, ginseng, gymnema, banaba, cinnamon, fenugreek, and kudzu, all of which are present in GlucoSupreme™ Herbal.
The research team hypothesizes that GlucoSupreme™ Herbal will demonstrate superior improvements in markers of glycemic control than placebo over twelve weeks of daily supplementation among a sample of healthy adults. The research team aims to conduct a randomized, placebo-controlled, double-blinded clinical trial to evaluate this hypothesis among a diverse sample of 40 prediabetic adults, and will implement a 1:1 study allocation ratio. This study will utilize an adaptive sample size re-estimation (SSR) approach where participant enrollment may be extended beyond the originally planned sample size if interim effect size is smaller than anticipated, but still promising, thereby preserving study power; this will be determined by examination of available unblinded endpoint data by an independent statistician after 30 subjects are enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each daily serving of four GlucoSupreme™ Herbal tablets includes extracts from: cinnamon bark (Cinnamomum cassia) 500 mg, banaba leaf (Lagerstroemia speciosa standardized to 1% corosolic acid) 200 mg, kudzu root (Pueraria lobata standardized to 40% isoflavones) 200 mg, fenugreek seed (Trigonella foenum-graceum standardized to contain 60% saponins) 200 mg, and gymnema leaf (Gymnema sylvestre standardized to contain 25% gymnemic acid). Additionally, American ginseng root (Panax quinquefolius standardized to contain 5% ginsenosides) 200 mg, and berberine HCl derived from bark (Berberis aristata) 500 mg. Other ingredients include Cellulose (capsule), microcrystalline cellulose, silicon dioxide, and vegetable stearate.
Dietary Supplement: GlucoSupreme™ Herbal
The placebo utilized in this clinical trial will be formulated by the manufacturer to be as similar as possible to the active intervention in appearance, odor, and other key characteristics. Packaging for the control will be identical to packaging for the Active Comparator.
Other: Placebo
This study will assess changes in glycemic parameters and other biomarkers over a twelve week period, with two blood draws (Baseline and 12 weeks). Additionally, an IRB-approved research associate will call each study participant at the 6-week mid-point of the study to assess compliance and collect data on any adverse events.
The placebo utilized in this clinical trial will be formulated by the manufacturer to be as similar as possible to the active intervention in appearance, odor, and other key characteristics. Packaging for the control will be identical to packaging for the Active Comparator.
Fasting Blood Glucose
Elevated fasting blood glucose is one of the markers of the prediabetic state. According to American Diabetes Association criteria, the prediabetic fasting blood glucose range is 100 to 125 mg/dL (5.6 to 6.9 mmol/L). After fasting for 8-12 hours, \> 0.5mL of blood will be collected from each participant, followed by centrifuge separation of plasma from cells within 45 minutes of collection. After maintaining the plasma fasting blood glucose at room temperature, it will be analyzed using standard enzymatic methodology.
Time frame: Baseline and study end (12 weeks from baseline)
Glycated hemoglobin/A1C (HbA1c)
Elevated HbA1c is another one of the markers of the prediabetic state and is defined as being within the range of 5.7-6.4%. A four mL sample of whole blood will be obtained from participants using techniques described above, and placed in an EDTA, lithium heparin, or sodium fluoride tube, followed by analysis using the Roche Tina Quant (Roche, Germany).
Time frame: Baseline and study end (12 weeks from baseline)
Fasting insulin
In prediabetes, pancreatic beta cells can no longer produce enough insulin to overcome insulin resistance, which can cause blood glucose levels to rise above the normal range. Thus, fasting insulin is a glycemic parameter of interest and is also used to determine insulin resistance. While normal values for fasting insulin are \<25 microU/L, fasting insulin can vary widely among prediabetic individuals. After fasting for 8-12 hours, 0.8mL blood serum will be obtained from each participant. This fasting insulin assay will be performed using a 2-site electrochemiluminescent immunoassay on the Roche automated platform (Roche, Germany.).
Time frame: Baseline and study end (12 weeks from baseline)
Insulin Resistance (HOMA-IR)
Insulin resistance often sets the stage for progression to T2D by placing a high demand on insulin-producing beta cells during a prediabetic state. The advantage of using the validated HOMA-IR calculation is its relative simplicity and low-cost since it is derived from other primary outcomes of interest in this study. HOMA-IR is calculated as: \[Fasting insulin (microU/L) x Fasting Blood Glucose (nmol/L)\]/22.5.
Time frame: Baseline and study end (12 weeks from baseline)
β-cell function (HOMA-β)
Pancreatic beta cells (β-cells) produce insulin. Thus, their function is of interest in this prediabetic study population. As is the case with HOMA-IR, this formula utilizes values from our other study outcomes. HOMA- β is calculated as: (20 x Fasting insulin \[microU/L\])/(Fasting blood glucose \[mmol/l\] - 3.5).
Time frame: Baseline and study end (12 weeks from baseline)
Quantitative Insulin Sensitivity Check Index (QUICKI)
The validated QUICKI measurement to assess insulin sensitivity has also been studied in herbal dietary supplement clinical trials. QUICKI is calculated as: 1/(log-fasting blood glucose \[mg/dL\] + log-fasting insulin \[uU/mL\]).
Time frame: Baseline and study end (12 weeks from baseline)
Fructosamine
Many serum proteins are involved in glucose synthesis. Fructosamine represents the degree of glycation in these proteins, and is the concentration of plasma glucose over the lifetime of the protein. This useful test has been utilized in previous clinical studies of natural products3 4 and is an adjunct to the A1C and other fasting glycemic measurements, and reflects intermediate-term (previous 2-3 weeks) glycemic change. One mL of serum or plasma will be collected, followed by centrifuge separation within 45 minutes of collection, and analyzed using standard colorimetric assay methodology (LabCorp, Inc.).
Time frame: Baseline and study end (12 weeks from baseline)
GlycoMark
A blood test commonly used in clinical practice to determine peak hyperglycemia. The GlycoMark test provides accurate recognition of recent glycemic deterioration or improvement (within the previous 2-4 weeks)5 6 and is commonly given adjacently to A1C (a longer-term indicator of glycemic change) in clinical practice. One mL of serum or plasma will be collected, followed by centrifuge separation within 60 minutes of collection, and analyzed using standard enzymatic colorimetric assay methodology (LabCorp, Inc.).
Time frame: Baseline and study end (12 weeks from baseline)
Lipid profile
A standard lipid panel consisting of total cholesterol, LDL, HDL, and triglycerides will be compared at baseline and the 12-week follow up visit. One mL of serum or plasma will be collected for all lipid parameters after 8 -12 hours of fasting and in the manner as described above, followed by centrifuge separation within 45 minutes of collection, and analyzed using standard enzymatic methodology (LabCorp, Inc.).
Time frame: Baseline and study end (12 weeks from baseline)
Inflammation
High-sensitivity C-reactive protein (Hs-CRP) is a common measure of inflammation that is commonly collected in clinical practice. Samples will undergo analysis by latex immunoturbidimetry on a COBAS Integra 800 (Roche, Germany).
Time frame: Baseline and study end (12 weeks from baseline)
Supplement compliance assessed using participant daily diary
Time frame: Study end (12 weeks from baseline)
Adverse events
Time frame: Throughout the study and at study end (12 weeks from baseline)
Plan to share: Undecided
Ran from Dec 2017 to primary completion in Sep 2019, 21 months.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 21 months is below that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore →