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The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

Primary Purpose

Diabetes in Adolescence, PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
AP029 mix
Placebo
Sponsored by
AronPharma Sp. z o. o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes in Adolescence focused on measuring Type II diabetes, Prediabetes, Disorders of Carbohydrate Metabolism, Chokeberry, Elderberry

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for type II diabetes: Women and men, 18-75 years old Patients diagnosed with type II diabetes mellitus Patients on metformin treatment up to 5 months BMI 20-35 kg/m2 Signed informed consent Inclusion Criteria for prediabetes: Women and men, 18-75 years old BMI 20-35 kg/m2 Fasting blood glucose levels between 100 mg/dl and 125 mg/dl (5.6-6.9 mmol/l) Signed informed consent Exclusion Criteria for type II diabetes: Patients diagnosed with type I diabetes Patients receiving insulin or other anti-diabetic medications Women who are pregnant, planning to become pregnant during the study, or breastfeeding Surgery within the last 6 months Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins Intake of supplements containing: white mulberry, chromium, berberine Patients receiving glucocorticosteroids, immunosuppressants Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant Acute inflammation (C-reactive protein >20mg/dl) Exclusion Criteria for prediabetes: Patients diagnosed with type I, II, LADA diabetes Patients receiving insulin or other anti-diabetic medications Women who are pregnant, planning to become pregnant during the study, or breastfeeding Surgery within the last 6 months Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins Intake of supplements containing: white mulberry, chromium, berberine Patients receiving glucocorticosteroids, immunosuppressants Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant Acute inflammation (C-reactive protein >20mg/dl)

Sites / Locations

  • Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-KoskoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

AP029 mix - type II diabetes

AP029 mix - prediabetes

Placebo - type II diabetes

Placebo - prediabetes

Arm Description

Patients with type II diabetes receiving metformin for up to 5 months

Patients with pre-diabetic

Patients with type II diabetes receiving metformin for up to 5 months

Patients with pre-diabetic

Outcomes

Primary Outcome Measures

Glucose level
Comparison of glucose level
Insulin level
Comparison of insulin level
Discomfort related to metformin side effects
Based on questionnaire

Secondary Outcome Measures

Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)
Comparison of lipid panel markers
hsCRP level
Comparison of hsCRP level
HbA1c level
Comparison of hbA1c level

Full Information

First Posted
August 9, 2023
Last Updated
August 9, 2023
Sponsor
AronPharma Sp. z o. o.
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1. Study Identification

Unique Protocol Identification Number
NCT05994586
Brief Title
The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism
Official Title
The Effect of Mix AP029 on the Efficacy of Metformin Therapy and Its Side Effects in Patients With Type II Diabetes and on Mechanisms Related to Prediabetes in Patients With Impaired Carbohydrate-lipid Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
November 26, 2023 (Anticipated)
Study Completion Date
November 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AronPharma Sp. z o. o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a positive effect on reducing side effects of metformin, while enhancing the therapeutic effect of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression into diabetes.
Detailed Description
Randomized, double-blind, cross over study conducted under medical supervision on 1) group of 20 patients with type II diabetes and 2) group of 10 patients with prediabetes. Study design: 2 months of AP029 supplementation, 1 month wash-out, 2 months of placebo intake. Patients will attend 4 visits. On each visit, the following parameters are analyzed: level of glucose, insulin, HbA1c, hsCRP lipid panel (total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL), HDL) and inflammatory and oxidative stress markers. In addition, a questionnaire of symptoms associated with metformin intake will be conducted

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes in Adolescence, PreDiabetes
Keywords
Type II diabetes, Prediabetes, Disorders of Carbohydrate Metabolism, Chokeberry, Elderberry

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AP029 mix - type II diabetes
Arm Type
Experimental
Arm Description
Patients with type II diabetes receiving metformin for up to 5 months
Arm Title
AP029 mix - prediabetes
Arm Type
Experimental
Arm Description
Patients with pre-diabetic
Arm Title
Placebo - type II diabetes
Arm Type
Placebo Comparator
Arm Description
Patients with type II diabetes receiving metformin for up to 5 months
Arm Title
Placebo - prediabetes
Arm Type
Placebo Comparator
Arm Description
Patients with pre-diabetic
Intervention Type
Dietary Supplement
Intervention Name(s)
AP029 mix
Intervention Description
Polyphenol-rich plant extracts Twice a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Twice a day
Primary Outcome Measure Information:
Title
Glucose level
Description
Comparison of glucose level
Time Frame
Baseline, 2 months, 3 months, 5 months
Title
Insulin level
Description
Comparison of insulin level
Time Frame
Baseline, 2 months, 3 months, 5 months
Title
Discomfort related to metformin side effects
Description
Based on questionnaire
Time Frame
Baseline, 2 months, 3 months, 5 months
Secondary Outcome Measure Information:
Title
Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)
Description
Comparison of lipid panel markers
Time Frame
Baseline, 2 months, 3 months, 5 months
Title
hsCRP level
Description
Comparison of hsCRP level
Time Frame
Baseline, 2 months, 3 months, 5 months
Title
HbA1c level
Description
Comparison of hbA1c level
Time Frame
Baseline, 2 months, 3 months, 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for type II diabetes: Women and men, 18-75 years old Patients diagnosed with type II diabetes mellitus Patients on metformin treatment up to 5 months BMI 20-35 kg/m2 Signed informed consent Inclusion Criteria for prediabetes: Women and men, 18-75 years old BMI 20-35 kg/m2 Fasting blood glucose levels between 100 mg/dl and 125 mg/dl (5.6-6.9 mmol/l) Signed informed consent Exclusion Criteria for type II diabetes: Patients diagnosed with type I diabetes Patients receiving insulin or other anti-diabetic medications Women who are pregnant, planning to become pregnant during the study, or breastfeeding Surgery within the last 6 months Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins Intake of supplements containing: white mulberry, chromium, berberine Patients receiving glucocorticosteroids, immunosuppressants Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant Acute inflammation (C-reactive protein >20mg/dl) Exclusion Criteria for prediabetes: Patients diagnosed with type I, II, LADA diabetes Patients receiving insulin or other anti-diabetic medications Women who are pregnant, planning to become pregnant during the study, or breastfeeding Surgery within the last 6 months Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins Intake of supplements containing: white mulberry, chromium, berberine Patients receiving glucocorticosteroids, immunosuppressants Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant Acute inflammation (C-reactive protein >20mg/dl)
Facility Information:
Facility Name
Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
City
Sopot
ZIP/Postal Code
81-820
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Khaidakov, PhD
Phone
798 210 651
Ext
+48
Email
barbara.khaidakov@aronpharma.pl
First Name & Middle Initial & Last Name & Degree
Dagmara Wiewiórkowska-Garczewska

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

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