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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04107987
Other study ID # P-20180017962
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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