Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes Mellitus, Metformin Efficacy, Gene Expression Profiles, Personalized Medicine

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 2 diabetes (duration of diabetes of at least 2 years)
age 40-70 yrs
HbA1c > 6.4 < 9.0

Exclusion Criteria:

insulin therapy
contraindications to metformin use

Sites / Locations

Casa Sollievo Della Sofferenza IRCCS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Metformin

Arm Description

At study entry, all oral hypoglycemic agents will be discontinued for 5 days and then metformin (2,550 mg/daily) will be given for 3 months. Fasting plasma glucose will be measured at baseline and 3 months after metformin treatment. Patients will be stratified according to the median value of metformin efficacy as indicated by fasting glucose change after metformin treatment (i.e. baseline fasting glucose minus 3-month fasting glucose). So, two subgroups of patients will be obtained, defined as relatively "high responders" (individual fasting glucose change > median value) or relatively "low responders" (individual fasting glucose change < median value) to metformin monotherapy.

Outcomes

Primary Outcome Measures

Fasting glucose change after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells

Changes in fasting glucose levels will be used to evaluate if metformin monotherapy efficacy in type 2 diabetic patients is predicted by mRNA and/or miRNA expression profiles. Please note that metformin major effect is to decrease hepatic glucose output and, therefore, to lower fasting plasma glucose which is, in fact, the clinical outcome used in this study. Finally, because of a very short wash-out period (i.e. 5 days) we will not be able to use HbA1c which will be inevitably conditioned by previous oral hypoglicemic therapy.

Secondary Outcome Measures

Change in fasting insulin levels after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells

Full Information

NCT ID

NCT01334684

First Posted

April 12, 2011

Last Updated

April 12, 2011

Sponsor

Casa Sollievo della Sofferenza IRCCS

Collaborators

University Hospital, Catania

1. Study Identification

Unique Protocol Identification Number

NCT01334684

Brief Title

Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes

Official Title

White Blood Cells Gene Expression Profiles as a Tool for Predicting Metformin Efficacy in Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2011 (undefined)

Primary Completion Date

April 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Casa Sollievo della Sofferenza IRCCS

Collaborators

University Hospital, Catania

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Our general aim is to investigate whether messenger RNA (mRNA) and/or microRNA (miRNA) expression profiles in white blood cells, predict metformin monotherapy efficacy in patients with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Type 2 Diabetes Mellitus, Metformin Efficacy, Gene Expression Profiles, Personalized Medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Other

Arm Description

At study entry, all oral hypoglycemic agents will be discontinued for 5 days and then metformin (2,550 mg/daily) will be given for 3 months. Fasting plasma glucose will be measured at baseline and 3 months after metformin treatment. Patients will be stratified according to the median value of metformin efficacy as indicated by fasting glucose change after metformin treatment (i.e. baseline fasting glucose minus 3-month fasting glucose). So, two subgroups of patients will be obtained, defined as relatively "high responders" (individual fasting glucose change > median value) or relatively "low responders" (individual fasting glucose change < median value) to metformin monotherapy.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Metformin, pills, 850 mg three times a day for three months

Primary Outcome Measure Information:

Title

Fasting glucose change after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells

Description

Changes in fasting glucose levels will be used to evaluate if metformin monotherapy efficacy in type 2 diabetic patients is predicted by mRNA and/or miRNA expression profiles. Please note that metformin major effect is to decrease hepatic glucose output and, therefore, to lower fasting plasma glucose which is, in fact, the clinical outcome used in this study. Finally, because of a very short wash-out period (i.e. 5 days) we will not be able to use HbA1c which will be inevitably conditioned by previous oral hypoglicemic therapy.

Time Frame

Baseline and after three months of metfomin therapy

Secondary Outcome Measure Information:

Title

Change in fasting insulin levels after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells

Time Frame

Baseline and after three months of metfomin therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Type 2 diabetes (duration of diabetes of at least 2 years) age 40-70 yrs HbA1c > 6.4 < 9.0 Exclusion Criteria: insulin therapy contraindications to metformin use

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Salvatore De Cosmo, MD

Phone

+39088241067

Email

s.decosmo@operapadrepio.it

First Name & Middle Initial & Last Name or Official Title & Degree

Ornella Ludovico, MD

Phone

+390882410625

Email

o.ludovico@operapadrepio.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Salvatore De Cosmo, MD

Organizational Affiliation

Casa Sollievo della Sofferenza IRCCS

Official's Role

Study Chair

Facility Information:

Facility Name

Casa Sollievo Della Sofferenza IRCCS

City

San Giovanni Rotondo

State/Province

Foggia

ZIP/Postal Code

71013

Country

Italy

12. IPD Sharing Statement

Citations:

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18945920

Citation

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Results Reference

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Type 2 Diabetes

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial