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Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Takeda Pharmaceuticals North America, Inc.
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
K. Sreekumaran Nair, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00443755
First received: February 26, 2007
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
Results First Received: April 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes
Insulin Resistance
Metabolic Syndrome
Interventions: Drug: metformin
Drug: pioglitazone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between 8/19/2005 and 8/24/2010 at the Mayo Clinic in Rochester, Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
48 Northern European Americans were assessed for eligibility and of those, 20 did not meet inclusion criteria.

Reporting Groups
  Description
Insulin Sensitizer Therapy Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
Placebo Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.

Participant Flow:   Overall Study
    Insulin Sensitizer Therapy     Placebo  
STARTED     14     14  
COMPLETED     12     13  
NOT COMPLETED     2     1  
Withdrawal by Subject                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Insulin Sensitizer Therapy Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
Placebo Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
Total Total of all reporting groups

Baseline Measures
    Insulin Sensitizer Therapy     Placebo     Total  
Number of Participants  
[units: participants]
 		  12     13     25  
Age  
[units: years]
Mean ± Standard Deviation 		  52.5  ± 15.6     52.2  ± 18.2     52.4  ± 16.6  
Gender  
[units: participants]
 		     
Female     7     8     15  
Male     5     5     10  
Region of Enrollment  
[units: participants]
 		     
United States     12     13     25  
Body Mass Index [1]
[units: kilograms/m^2]
Mean ± Standard Deviation 		  32.43  ± 5.65     29.67  ± 3.34     31.00  ± 4.71  
Fat-Free Mass  
[units: Kilograms]
Mean ± Standard Deviation 		  48.81  ± 14.29     46.67  ± 13.54     47.70  ± 13.66  
Body Fat  
[units: Percentage]
Mean ± Standard Deviation 		  46.49  ± 5.92     43.26  ± 9.17     44.81  ± 7.80  
Fasting Blood Glucose  
[units: milligrams per deciliter]
Mean ± Standard Deviation 		  126.25  ± 21.87     129.00  ± 26.32     127.68  ± 23.82  
Glycosylated Hemoglobin (HbA1c) [2]
[units: Percentage]
Mean ± Standard Deviation 		  5.97  ± 0.71     6.25  ± 0.65     6.11  ± 0.68  
Glucose Infusion Rate (GIR) [3]
[units: micromols/kilogram of FFM/minute]
Mean ± Standard Deviation 		  22.28  ± 14.67     23.40  ± 15.27     22.86  ± 14.68  
Insulin level  
[units: micro International Units per milliliter]
Mean ± Standard Deviation 		  15.68  ± 9.75     10.18  ± 5.70     12.82  ± 8.23  
Lipid Profile  
[units: milligrams per deciliter]
Mean ± Standard Deviation 		     
Triglycerides     131.42  ± 54.76     135.00  ± 51.36     133.28  ± 51.93  
High Density Lipoprotein-Cholesterol (HDL-C)     43.33  ± 12.78     39.23  ± 8.74     41.20  ± 10.84  
Non-HDL-Cholesterol     135.58  ± 26.17     132.46  ± 21.65     133.96  ± 23.47  
Fibrinogen  
[units: milligrams per deciliter]
Mean ± Standard Deviation 		  393.67  ± 78.63     418.92  ± 100.23     406.80  ± 89.57  
Plasminogen Activator Inhibitor 1 (PAI-1)  
[units: nanograms per milliliter]
Mean ± Standard Deviation 		  81.83  ± 22.01     55.85  ± 33.70     68.3  ± 31.1  
C-Reactive Protein (CRP)  
[units: milligrams per deciliter]
Mean ± Standard Deviation 		  0.42  ± 0.43     0.43  ± 0.49     0.42  ± 0.45  
Interleukin-6 (IL-6)  
[units: picograms per milliliter]
Mean ± Standard Deviation 		  2.46  ± 1.68     3.28  ± 4.79     2.88  ± 3.59  
Tumor Necrosis Factor-alpha (TNF-α)  
[units: picograms per milliliter]
Mean ± Standard Deviation 		  1.39  ± 0.57     2.98  ± 5.39     2.22  ± 3.91  
Adiponectin  
[units: milligrams per milliliter]
Mean ± Standard Deviation 		  6.08  ± 2.17     5.22  ± 2.13     5.63  ± 2.15  
[1] Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared.
[2] The HbA1c level reflects the average glucose (blood sugar) concentration over the previous 3 month period.
[3] FFM is Fat Free Mass



  Outcome Measures
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1.  Primary:   Change From Baseline in Insulin Sensitivity as Measured by Glucose Infusion Rate (GIR)   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Fasting Blood Glucose Level   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Insulin Levels   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Lipid Profile   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in the Thrombotic Biomarker Fibrinogen   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in the Thrombotic Biomarker Plasminogen Activator Inhibitor-1 (PAI-1)   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in the Inflammatory Biomarker Interleukin 6 (IL-6)   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in the Inflammatory Biomarker C-Reactive Protein (CRP)   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Inflammatory Biomarker Tumor Necrosis Factor-alpha (TNF-α)   [ Time Frame: Baseline, 3 month ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in the Inflammatory Biomarker Adiponectin   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 11

12.  Other Pre-specified:   Change From Baseline in Body Mass Index   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 12

13.  Other Pre-specified:   Change From Baseline in Body Fat   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 13

14.  Other Pre-specified:   Change From Baseline in Fat-Free Mass (FFM)   [ Time Frame: Baseline, 3 months ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: K. Sreekumaran Nair, MD, Ph.D.
Organization: Mayo Clinic
phone: 507-255-3605
e-mail: nair@mayo.edu


Publications of Results:


Responsible Party: K. Sreekumaran Nair, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00443755     History of Changes
Other Study ID Numbers: 05-004002, R01DK041973, KL2RR024151, UL1RR024150
Study First Received: February 26, 2007
Results First Received: April 22, 2013
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board