Dietary Modulation of Gene Expression and Metabolic Pathways in Glucose Metabolism (Sysdimet)

This study has been completed.
Sponsor:
Collaborators:
VTT Technical Research Centre, Finland
Wageningen University
Information provided by (Responsible Party):
Marjukka Kolehmainen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT00573781
First received: December 13, 2007
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

Professor Matti Uusitupa, University of Kuopio, Department of Clinical Nutrition (www.uku.fi) Docent Matej Oresic, VTT (www.vtt.fi) Ursula Schwab, PhD, Docent, Marjukka Kolehmainen, PhD, Docent, Leena Pulkkinen, PhD, Docent, David Laaksonen, MD, PhD, MPH, Docent, Kaisa Poutanen, DSc (Tech), Research Professor

ABSTRACT

The metabolic syndrome (MS) and type 2 diabetes (T2DM) are the most important health problems worldwide. In Finland the prevalence of T2DM is 12-15% among middle-aged people. The prevalence of less marked disturbances in glucose metabolism and MS is 30-40%. Because MS and T2DM are important risk factors for cardiovascular diseases (CVD), the leading cause of death in western countries, all efforts to reverse the epidemic increase in the incidence of MS and T2DM are warranted. The investigators have focused for years on the prevention and non-pharmacological treatment of T2DM and its complications including studies on genetic regulation of glucose and lipid metabolism after dietary modifications. In the investigators' recent projects, the investigators have studied the effects of long-term dietary interventions on gene expression profiles of fat tissue in subjects who are at risk of T2DM. The ultimate goal of these projects has been to identify genes and gene clusters and their biological pathways that respond to dietary modification and modulate glucose and lipid metabolism, and to develop dietary strategies for prevention of T2DM. The main goal of this project is to find nutrition related early biomarkers for progression of MS to T2DM by using modern technologies of systems biology (transcriptomics, metabolomics) of carefully conducted dietary interventions involving subjects with MS. The data will be analysed by using bioinformatics. The investigators reflect these new data to well-known risk factors for T2DM and CVD, e.g., insulin sensitivity, insulin secretion, serum lipids and inflammatory factors among others. In addition to interventions conducted earlier, a new intervention with a whole grain-berry-fish diet and a whole grain diet compared to a control diet with refined foods will be performed. The aim is to increase the investigators' understanding on the synergistic effects of these foods, because the investigators' previous interventions have shown that these individual foods have beneficial effects on glucose and lipid metabolism. On the contrary, diets with refined foods may be harmful in long-term due to its high insulin response, which may through chronic stress lead to both insulin resistance and beta-cell damage.

The significance of this project is to increase understanding of the pathophysiology of MS, T2DM and CVD in physiological, cellular and genetic systems, which may lead to more effective and individualised strategies for treatment and prevention, and better identification of high-risk individuals responsive to specific dietary modifications. Increasing knowledge of dietary factors involved in the progression of MS to T2DM and CVD offers new opportunities to individually tailored diets in the management and prevention of these disorders. The results will also be beneficial for the food industry in developing new functional foods. These results and actions may help delay or even stop the epidemic of MS and T2DM and their negative effect on public health currently seen in Finland and worldwide.


Condition Intervention Phase
Metabolic Syndrome
Obesity
Impaired Glucose Tolerance
Impaired Fasting Glucose
Dietary Supplement: Diet with increased intake of rye bread, berries and fish
Dietary Supplement: Increased intake of whole grain and rye bread
Dietary Supplement: Control diet with decreased intake of rye bread, berries and fish
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Systems Biology Approach to Understand Dietary Modulation of Gene Expression and Metabolic Pathways in Subjects With Abnormal Glucose Metabolism (Sysdimet)

Resource links provided by NLM:


Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • Changes in glucose metabolism, changes in transcriptomic and metabolomic profiles [ Time Frame: By 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interaction between the diet and genetic factors within treatment groups [ Time Frame: By 2010 ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Diet with increased intake of rye bread, berries and fish
Dietary Supplement: Diet with increased intake of rye bread, berries and fish
Dietary modification with commercial food items
Experimental: B
Increased intake of whole grain and rye bread
Dietary Supplement: Increased intake of whole grain and rye bread
Dietary modification with commercial food items
Active Comparator: C
Control diet with decreased intake of rye bread, berries and fish
Dietary Supplement: Control diet with decreased intake of rye bread, berries and fish
Dietary modification with commercial food items

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • impaired glucose tolerance (oral glucose tolerance test with 2-h glucose concentration 7,8-11,0 mmol/l) OR
  • impaired fasting glucose fasting plasma glucose concentration 5,6-6,9 mmol/l = IFG)
  • and two of the criteria for metabolic syndrome:
  • BMI 26-39 kg/m2
  • Waist circumference > 102 cm (men) or > 88 cm (women)
  • hypertriglyceridemia (fasting serum triglyceride conc > 1,7 mmol/l),
  • HDL-cholesterol (fasting serum HDL conc < 1,0 mmol/l for men and < 1,3 mmol/l for women)
  • Blood pressure ≥ 130/≥ 85 mmHg

Exclusion Criteria:

  • BMI > 40 kg/m2
  • fasting serum triglyceride conc > 3.5 mmol/l
  • fasting serum cholesterol > 8 mmol/l
  • type 1 or 2 diabetes
  • abnormal liver, kidney or thyroid function
  • large alcohol intake (women >16, men > 24 doses (4cl liquor or equivalent) during week)
  • inflammatory bowel disease
  • disease that prevents participation
  • neuroleptic neuroleptic cortisone medication
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00573781

Locations
Finland
University of Kuopio, Department of Clinical Nutrition
Kuopio, Finland, 70211
Sponsors and Collaborators
Marjukka Kolehmainen
VTT Technical Research Centre, Finland
Wageningen University
Investigators
Study Director: Matti IJ Uusitupa, professor, rector University of Kuopio, Department of Clinical Nutrition
  More Information

No publications provided by University of Eastern Finland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marjukka Kolehmainen, Senior scientist, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT00573781     History of Changes
Other Study ID Numbers: 56/2007, 117844 by Finnish Academy
Study First Received: December 13, 2007
Last Updated: April 16, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by University of Eastern Finland:
Systems biology
Nutrigenomics
Metabolomics
Gene expression
Fat tissue
Peripheral mononuclear cells
Gene clusters
Gene expression profiles
Personal diets
Metabolic syndrome
Type 2 Diabetes
Atherosclerosis

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Intolerance
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014