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

Dysglycemia Clinical Trial

Official title:

An Evaluation of a Nutraceutical With Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107987
• Other study ID #: P-20180017962
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: September 2019
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dysglycemia

Intervention

Dietary Supplement:
• Reglicem
Reglicem is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Matteo	Pavia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of dysglicemia	Oral glucose tolerance test	3 months