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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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2018-10-01
2019-08-31
Brief Summary
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Detailed Description
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The investigators will enroll patients with impaired fasting plasma glucose (IFG) or impaired glucose tolerance (IGT), not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents). Patients will be randomized to take placebo or Glicoset® 1000 for 3 months, in a randomized, double-blind, placebo-controlled design. Glicoset® 1000 and placebo will be self-administered once a day, 1 tablet during the breakfast.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Glicoset
Glicoset is a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate
Glicoset
Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate
Placebo
Placebo
Patients will take placebo
Interventions
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Glicoset
Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate
Placebo
Patients will take placebo
Eligibility Criteria
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Inclusion Criteria
* Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)
Exclusion Criteria
* Patients with impaired hepatic function
* Patient with impaired renal function
* Patients with gastrointestinal disorders
* Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
* Patients with weight change of \> 3 Kg during the preceding 3 months
* Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
* Patients taking (within the previous 3 months) hypoglycemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, anti-depressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
* Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.
18 Years
75 Years
ALL
No
Sponsors
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University of Pavia
OTHER
Responsible Party
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Giuseppe Derosa
MD, PhD, FESC
Locations
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IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Countries
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Other Identifiers
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P-20180016364
Identifier Type: -
Identifier Source: org_study_id
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