Status:
COMPLETED
Wholegrain Cereal Diet and Insulin Sensitivity
Lead Sponsor:
Federico II University
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
A diet with the multiple beneficial characteristics of whole grains and, more in general, of "healthy cereals" favorably influences glucose and insulin metabolism in subjects with metabolic syndrome. ...
Eligibility Criteria
Inclusion
- Subjects with at least three of the following criteria of metabolic syndrome according to ATPIII-NCEP criteria:
- waist circumference \>102 for men and 88 for women,
- fasting total serum triacyglycerol concentration \>1.7 mmol/L,
- fasting HDL cholesterol \<1.0 mmol/L for men or \<1.3 mmol/L for women,
- IFG (plasma glucose between 6.1 and 6.9 mmol/L) or
- blood pressure \>130/85 mmHg or use of blood pressure medication
- Hypertension in stable control (BP \<135/80 mmHg) by means of drugs, which will not be allowed to be changed during the study
- Absence of main cardiovascular events (IMA, Ictus)
Exclusion
- Diabetes mellitus diagnosed according to history of diabetes or blood glucose ≥ 200 mg/dL (11.1 mmol/L) 2 hours after a 75 g Oral glucose tolerance test (OGTT) to be performed during the run-in period in all the subjects
- Any drug able to influence glucose and lipid metabolism (hypolipidemic drugs, cholesterol lowering foodstuffs, anti-inflammatory drugs)
- Renal failure (serum creatinine \> 1.5 mg/dL) and liver failure (ALT/AST\> 2 times above normal values)
- Anemia (Hb \< 12g/dl) or any other chronic disease
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00945854
Start Date
March 1 2008
End Date
December 1 2010
Last Update
June 26 2014
Active Locations (1)
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1
Dept. of Clinical and Experimental Medicine, Federico II University
Naples, Italy, 80131