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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04107987
Recruitment Status : Completed
First Posted : September 27, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Giuseppe Derosa, 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.

Condition or disease Intervention/treatment Phase
Dysglycemia 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.

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Study Type : Interventional  (Clinical Trial)
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 : October 1, 2018
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Progression of dysglicemia [ Time Frame: 3 months ]
    Oral glucose tolerance test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107987


Locations
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Italy
IRCCS Policlinico San Matteo
Pavia, Lombardia, Italy, 27100
Sponsors and Collaborators
University of Pavia

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Responsible Party: Giuseppe Derosa, MD, PHd, FESC, University of Pavia
ClinicalTrials.gov Identifier: NCT04107987    
Other Study ID Numbers: P-20180017962
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inositol
Chromium
Curcumin
Picolinic acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Trace Elements
Iron Chelating Agents
Chelating Agents
Sequestering Agents