Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia

Phase 3

Completed

• Conditions: Dysglycemia
• Interventions: Other: Placebo; Dietary Supplement: Reglicem

• Registration Number: NCT04107987
• Lead Sponsor: University of Pavia

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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-09
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Reglicemi	Reglicem	Reglicemi is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate

Primary Outcome Measures

Name	Time	Method
Progression of dysglicemia	3 months	Oral glucose tolerance test

Trial Locations

Locations (1)

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Lombardia, Italy