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

NCT04107987 | Completed Phase 3

• 1 other identifier: P-20180017962
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysglycemia

Outcome Measures

Primary Outcomes (1)

• Progression of dysglicemia

  Oral glucose tolerance test

  3 months

Study Arms (2)

Reglicemi

ACTIVE COMPARATOR

Reglicemi is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate

Dietary Supplement: Reglicem

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Reglicem DIETARY_SUPPLEMENT

Reglicem is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate

Reglicemi

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
• Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHd, FESC

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: October 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Locations

IT (1)