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

Sponsor
University of Pavia (Other)
Overall Status
Completed
CT.gov ID
NCT04107987
Collaborator
(none)
148
Enrollment
1
Location
2
Arms
11
Actual Duration (Months)
13.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Reglicem
  • Other: Placebo
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
An Evaluation of a Nutraceutical With Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Aug 31, 2019
Actual Study Completion Date :
Aug 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Reglicemi

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

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

Placebo

Other: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Progression of dysglicemia [3 months]

    Oral glucose tolerance test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Policlinico San Matteo Pavia Lombardia Italy 27100

Sponsors and Collaborators

  • University of Pavia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Giuseppe Derosa, MD, PHd, FESC, University of Pavia
ClinicalTrials.gov Identifier:
NCT04107987
Other Study ID Numbers:
  • P-20180017962
First Posted:
Sep 27, 2019
Last Update Posted:
Oct 2, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 2, 2019