Status:
COMPLETED
RCT of a Polyherbal Dietary Supplement for Prediabetes
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Alliance Institute for Integrative Medicine
Conditions:
Prediabetic State
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 o...
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Prediabetic blood measurement (HbA1C) of 5.7-6.4% and/or fasting blood glucose of 100-125 mg/dl and/or 2-hour Oral Glucose Tolerance Test blood glucose value of 140 mg/dl-199 mg/dl1 2) taken within the last 12 weeks
- Agree to continue with current diet and refrain from taking any new nutritional or herbal supplements
- Able to understand and write English
- Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
Exclusion
- Current daily use of any oral hypoglycemic medication or insulin injection
- Current daily use of any supplement containing the herbs in the study supplement
- Known allergies to any substance in the study supplement
- Current daily tobacco smoker
- Currently pregnant or planning to become pregnant in the next 12 weeks
- Any current or previous diagnosis of diabetes (Type 1 or Type 2)
- Myocardial infarction, vascular surgery, or stroke in the past year
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03388762
Start Date
December 5 2017
End Date
January 1 2020
Last Update
June 28 2022
Active Locations (4)
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1
University of Maryland Center for Diabetes and Endocrinology
Baltimore, Maryland, United States, 21201
2
University of Maryland Family Medicine Associates
Baltimore, Maryland, United States, 21201
3
University of Maryland School of Medicine, Department of Family and Community Medicine, East Hall
Baltimore, Maryland, United States, 21201
4
Alliance Integrative Medicine
Cincinnati, Ohio, United States, 45236