Dysglycemia Clinical Trial
Official title:
An Evaluation of a Nutraceutical With Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia
Verified date | September 2019 |
Source | University of Pavia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not adequately treated. The variation of glycemic balance can lead to cardiovascular disorders. The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with dysglycemia.
Status | Completed |
Enrollment | 148 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT) - Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Policlinico San Matteo | Pavia | Lombardia |
Lead Sponsor | Collaborator |
---|---|
University of Pavia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression of dysglicemia | Oral glucose tolerance test | 3 months |
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