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Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes

This study has been completed.
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01248286
First received: November 17, 2010
Last updated: June 2, 2011
Last verified: June 2011
History of Changes
  Purpose

Food products derived from cereal grains constitute a major part of the daily diet of many Americans . For example, a typical Chinese American eats rice about 9.5 times a week on an average. However, most of these foods are derived from refined grain. During the refining process grains are stripped of their bran and germ which results in depletion of several biologically active constituents including fiber, anti-oxidants, phytoestrogens and minerals. From observational studies there is evidence for a protective effect of whole-grain foods with regard to the development of type 2 diabetes. More recently, higher intake of whole grains was also associated with decreases in insulin resistance - a risk factor related to the development of type 2 diabetes.

In this randomized study the investigators plan to replicate this beneficial effect of improving insulin sensitivity in patients with pre-diabetes and go a step further by exploring the potential mechanisms by which this benefit may occur. The investigators will assess the effect of consuming a whole-grain-rich diet on levels of advanced glycation endproducts (AGE), RAGE (receptor for AGE) and markers of inflammation and oxidative stress - all of which have been shown to play an important role in the pathogenesis of diabetes mellitus. The investigators will also look for correlations between the levels of these markers with insulin sensitivity to identify potential mechanisms of pathogenesis.


Condition Intervention
Diabetes
Prediabetes
 Other: Whole grain rice
Other: Refined grain rice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Homeostatic Model Assessment (HOMA) Index [ Time Frame: 0 ] [ Designated as safety issue: No ]
    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels

  • Homeostatic model assessment(HOMA) index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels

  • Homeostatic model assessment (HOMA) index. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Estimates insulin resistance and β-cell function from fasting glucose and insulin levels


Secondary Outcome Measures:
  • Carboxymethyl lysine (CML) [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Advanced glycation end product (in blood and urine)

  • Methylglyoxal (MG) [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Advanced glycation end product (in blood and urine)

  • IL-6 [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Inflammatory marker

  • Receptor for advanced glycation endproducts (RAGE) [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Receptor for advanced glycation endproducts

  • Sirtuin 1 [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
    A protein that in humans is encoded by the SIRT1 gene and regulates processes such as apoptosis and muscle differentiation by deacetylating key proteins. It is down regulated in cells that have high insulin resistance and inducing its expression increases insulin sensitivity


Enrollment: 100
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole grain rice Other: Whole grain rice
Whole grain rice arm (treatment arm): Subjects will be provided a supply of whole grain rice and will be asked to prepare rice items in their meal with the provided whole grain rice while participating in the study
Active Comparator: Refined grain rice Other: Refined grain rice
Refined grain rice arm (control arm): Subjects will be provided a supply of refined grain rice and will be asked to prepare rice items in their meal with the provided refined grain rice while participating in the study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years to unlimited, both genders.
  2. At least one meal per day included rice in the seven days prior to enrolment.
  3. No current diagnosis of Diabetes Mellitus (DM).
  4. Fasting blood glucose value between 100 to 125 mg/dl and/or Hemoglobin A1c levels between 5.7%-6.4%.
  5. ≥ 2 visits with primary care physician to establish compliance

Exclusion Criteria:

  1. Special diets (e.g. vegetarian)
  2. Use of medications that would affect blood sugar levels (e.g. steroids)
  3. Allergy to any type of grain
  4. Body weight fluctuation over the past 180 days of ≥ 10%
  5. Planning to significantly change level of physical activity during the time of study.
  6. Planning to move out of town or take a vacation for ≥ 14 days during the time of the study
  7. Current smoker
  8. Consumption of greater than 2 alcoholic drinks per day
  9. History of malignancy and overt cardiovascular disease (apart from hypertension).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248286

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Jaime Uribarri, MD Mount Sinai School of Medicine
  More Information

Additional Information:
Click here for more information about Jaime Uribarri, MD, the principal investigator of this study.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jaime Uribarri, MD, Principal Investigator, Department of Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01248286     History of Changes
Other Study ID Numbers: 10-0924 0001 01 ME, 10-0924
Study First Received: November 17, 2010
Last Updated: June 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Diabetes
Prediabetes
Prevention
 Whole grain
Advanced glycation end products
Insulin sensitivity

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperglycemia
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013