An Evaluation of a Nutraceutical With Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Dysglycemia
- Sponsor
- University of Pavia
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Progression of dysglicemia
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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. The investigators will enroll patients with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), not taking other hypoglycemic compounds. Patients will be randomized to take Reglicem® or placebo for 3 months, in a randomized, double-blind, placebo-controlled design. Reglicem® and placebo will be self-administered once a day, 1 tablet during the breakfast.
Investigators
Giuseppe Derosa
MD, PHd, FESC
University of Pavia
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Progression of dysglicemia
Time Frame: 3 months
Oral glucose tolerance test