Status:
COMPLETED
Nutraceutical on Hyperglycemia
Lead Sponsor:
University of Pavia
Conditions:
Dysglycemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dys...
Detailed Description
The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dys...
Eligibility Criteria
Inclusion
- Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
- Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)
Exclusion
- Patients with type 1 or type 2 diabetes mellitus
- 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.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04107922
Start Date
October 1 2018
End Date
August 31 2019
Last Update
October 1 2019
Active Locations (1)
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1
IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy, 27100