Dysglycemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTReglicem
Reglicem is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate
OTHERPlacebo
Placebo
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of dysglicemia | 3 months | Oral glucose tolerance test |
Countries
Italy
Outcome results
None listed