- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02634216
Effects of Capros in Patients With Type-1 Diabetes (CarposT1D)
Effects of Capros Supplementation on Hyperglycemia in Patients With Type-1 Diabetes
Study Overview
Detailed Description
There are a total of 4 study visits,over the course of 12 weeks. These visits will occur on weeks 1, 4, 8, and 12. At each study visit the the following will be recorded: Age, Sex, Pulse, height, weight, CGM real time measurement and the following non-medical information will be recorded: Address, Phone number and Email address ( will be recorded at the first visit and will be asked if anything has changed at the reoccurring visits). The following will happen at each visit:
Visit 1 (Week 0): The subject will be presented with informed consent. Data will be collected on a data collection sheet, a finger stick for A1C will be obtained (if not completed as SoC), Continuous Glucose Monitoring will be downloaded, UPT for WCBP will be performed, the subject will be given a 4-week supply of the Capros supplement and a subject diary. The subject will be given a subject diary to document their morning/evening sugar and the time of when participants take the supplements. The subject will be asked to bring in the diary to each follow-up visit to check for compliance verification.
Visit 2 and 3 (Week 4 and 8): The following activities will take place during these visits: AE review, concomitant medications review, weight, vital signs, CGM download, pill count and distribution, collect previous diary and provide new.
Visit 4 (Week 12): The following activities will take place during these visits: AE review, concomitant medications review, weight, vital signs, CGM download, pill count, collect previous diary. Also, at this visit, a finger stick for A1C (if not completed as SoC), no further distribution of supplements.
Taking the supplement: After receiving the supplement, the subject is instructed to take 2 capsules per day by mouth, once with food around lunchtime and once with food around dinner time for a total of 12 weeks. The subjects will be asked to keep all empty bottles/ any remaining Capros supplements and bring them to each follow-up visit for a compliance check. Participants will receive a new 4-week supply of supplements at study visits 2 and 3.
Risks for participating in this study are extremely low. Capros is a dietary supplement derived from the Indian Gooseberry, and contains no artificial ingredients, is non-toxic and is safely tolerated among humans. Capros is currently sold over the counter in the U.S. and has no known side effects; however an allergic reaction to the supplement is possible.
There is a potential risk for hypoglycemia while taking this supplement. In the even that this occurs, subjects are instructed to follow their primary care physician instructions for this and record it on their data log.
This is not a treatment study so subjects may have no direct benefit while taking the supplement. The investigators are looking to monitor and observe if any changes take place with participants blood sugar level over the course of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43203
- Carepoint East 543 Taylor Ave.
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Columbus, Ohio, United States, 43210
- Martha Morehouse Medical Plaza 2050 Kenny Road
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Columbus, Ohio, United States, 43212
- Davis Heart and Lung Research Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must be 10 - 60 yrs. of age
- Type 1 Diabetes using Continuous Glucose Monitoring (CGM) for at least the last 3 months
- Less than 10% variation in prescribed long acting dosages in the previous 3 months
Exclusion Criteria:
- Individuals who are deemed unable to understand the procedures, risks and benefits of the study, i.e. informed consent will be excluded from the study
- Females who are pregnant
- Individuals who are therapeutically immuno-compromised
- Prisoners
- Anyone with a known allergy to amla fruit
- Current use of any of the following medications will result in exclusion:
- Steroids (Prednisone, etc.)
- Immunosuppressants
- Accutane (last 6 months)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Type 1 Diabetics using CGM
Type 1 diabetics using Continuous Glucose MonitoringCGM to take 500 mg daily of Capros supplement (250 mg twice a day) at lunch and dinner.
|
250 mg BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Capros on Blood Glycemic Index
Time Frame: 12 weeks
|
To determine the effect on blood glycemic index in Type 1 Diabetics with taking the nutritional supplement Capros
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gayle M. Gordillo, M.D., Ohio State University
Publications and helpful links
General Publications
- Hiraganahalli BD, Chinampudur VC, Dethe S, Mundkinajeddu D, Pandre MK, Balachandran J, Agarwal A. Hepatoprotective and antioxidant activity of standardized herbal extracts. Pharmacogn Mag. 2012 Apr;8(30):116-23. doi: 10.4103/0973-1296.96553.
- Sabu MC, Kuttan R. Anti-diabetic activity of medicinal plants and its relationship with their antioxidant property. J Ethnopharmacol. 2002 Jul;81(2):155-60. doi: 10.1016/s0378-8741(02)00034-x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014H0206
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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