Effect of Phytoecdysterone Administration in Subjects With Prediabetes
NCT ID: NCT03906201
Last Updated: 2019-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
34 participants
INTERVENTIONAL
2019-02-06
2020-07-31
Brief Summary
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Detailed Description
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The study design is a randomized, randomized clinical trial with a control group in two groups: an intervention group with ecdysterone 300mg every 24 hours for 12 weeks (approximately 90 days) and an approved placebo control group (magnesia stearate) ) at 300mg every 24 hours for 12 weeks (approximately 90 days).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control Group
Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 with placebo treatment
Placebo
no pharmacologic effect
Ecdysterone Group
Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 whit ecdysterone treatment
Ecdysterone
Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic
Interventions
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Ecdysterone
Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic
Placebo
no pharmacologic effect
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. \- Oral Glucose Tolerance Test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)
3. \- A1C 5.7-6.4% (39-47 mmol/mol).
4. \- Body Mass Index \>25 kg/m2 or \>23 kg/m2
5. \- Adults who have one or more of the following risk factors:
* First-degree relative with diabetes
* High-risk race/ethnicity
* History of CVD
6. \- Blood Pressure \<140/90 mmHg without therapy for hypertension
7. \- HDL cholesterol level \<0.35 mg/dL (0.90 mmol/L) and/or a triglyceride level \>0.250 mg/dL (2.82 mmol/L)
Exclusion Criteria
3.- Hypertension 4.- Cancer, 5.- Hyperthyroidism 6.- Hypothyroidism 7.- Immunologic disease 8.- Kidney disease 9.- Hepatic disease 10.- Cardiovascular disease 11- Abaqus activity 12.-Alcoholic activity.
30 Years
60 Years
ALL
No
Sponsors
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University of Guadalajara
OTHER
Responsible Party
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Ana Lilia Fletes Rayas
Reseach Professor Associated
Principal Investigators
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ANA FLETES
Role: PRINCIPAL_INVESTIGATOR
University of Guadalajara
Locations
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Ana Fletes
Guadalajara, Jalisco, Mexico
Countries
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Central Contacts
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Facility Contacts
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ANA FLETES
Role: primary
References
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Related Links
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The journal of clinical and applied research and education. Diabetes Care. American Diabetes Association. Standards of Medical Care in Diabetes-2019.
Other Identifiers
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125/18
Identifier Type: -
Identifier Source: org_study_id