Berberine, Curcumin, Inositol, Banaba and Chromium Picoli... | NCT04107987

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

NCT04107987

Sponsor

University of Pavia

Status

Completed

Last Update Posted

Oct 2, 2019Actual

Enrollment

148Actual

Phase

Phase 3

Conditions

Dysglycemia

Interventions

Reglicem
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Aug 31, 2019Actual

Completion Date

Aug 31, 2019Actual

First Submitted Date

Sep 25, 2019

First Submission Date that Met QC Criteria

Sep 25, 2019

First Posted Date

Sep 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2019

Last Update Posted Date

Oct 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Reglicem	Dietary Supplement	Reglicem is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate	Reglicemi

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression of dysglicemia	Oral glucose tolerance test	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided