Type 2 Diabetes Mellitus
Conditions
Keywords
pistachio intake, insulin resistance, type 2 diabetes mellitus
Brief summary
Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated abnormalities.
Detailed description
In free-living overweight or obese adult with impaired fasting glucose or impaired glucose tolerance we will compare the effects of a pistachio-rich diet or a Mediterranean Diet on: * Fasting glucose levels, hemoglobin A1c, insulin, C peptide, HOMA IR, advanced glycation end products and soluble receptor of advanced glycation-end products. * Peripheral haemostatic parameters. * Plasma inflammatory markers. * Lymphocyte expression of toll-like receptors, C peptide, resistin and interleukin-6 in peripheral leukocytes. * Lymphocyte glucose transport and expression of glucose transporter 4 in peripheral blood leukocytes. * Platelet function including platelet number, mean platelet volume, platelet factor 4 levels and urinary 11-dehydro-thromboxane B2.
Interventions
DIETARY_SUPPLEMENTPistachios
Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period. Total duration of intervention and follow-up is nine months.
OTHERcontrol diet
Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period. Total duration of intervention and follow-up is nine months.
Sponsors
Western Pistachio Association
Institut Investigacio Sanitaria Pere Virgili
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI less than 35 kg/m2. * Fasting plasma glucose levels between 100 and 125 mg/dl or * Oral glucose tolerance test of 140 to 199 mg/dl.
Exclusion criteria
* Diabetes mellitus. * Alcohol, tobacco, or drug abuse. * Significant liver, kidney, thyroid, or other endocrine diseases. * Frequent consumption of nuts or known history of allergy to them. * Use of plant sterol, oral antidiabetic drugs, supplemental use of phyllium, fish oil supplements and multivitamins, vitamin E or other antioxidant supplements. * Bad dentures, implying difficulty to chew pistachios. * Being pregnant or wishing to become a pregnant 6 months before or during the study, lactating 6wk before or during the study. * Following vegetarian or weight loss diets. * Other medical or social conditions that difficult the compliance to the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in circulating levels of glucose and insulin according to the intervention arm | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm | Measurement of circulating glucose and insulin levels and cellular glucose uptake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in haemostatic parameters according to the intervention arm | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm | Tissue factor, fibrinogen, PAI-1, vWF will be measured. |
| Changes from baseline in HL and LDL size according to the intervention arm | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm | Plasmi lipoprotein size will be measured by polycacrylamide gradient gel electrophoresis |
| Changes in advanced glycation end products according to the intervention arm | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm | Advanced glycation end products and soluble receptor of advanced glycation-end produtcs will be measured |
| Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm | Cpeptide, resistin, IL-6, IL-18, Ghrelin, leptin, adiponectin, GLP-1 and oxidized LDL will be measured. |
| Changes from baseline in cellular glucose uptake according to the intervention arm | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm | Glucose uptake and GLUT4 protein levels will be assessed in peripheral leukocytes |
| Changes from baseline in platelet function according to the intervention arm | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm | Platelet number, mean platelet volume and platelet factor 4 in blood, and urinary levels of 11-dehydro-thromboxane B2 will be assessed. |
| Changes from baseline in telomeric length of leukocytes (LTL) | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first intervention arm. Measurements will be not analysed after the second period due to expected carry-over effect. | Telomere lenght will be evaluated as a biomarker of biological age and general health status. Telomere attrition may play an important role in the pathogenesis and severity of type 2 diabetes (T2D) increasing the probability of beta-cell senescence, leading to reduced cell mass and decreased insulin secretion. |
| Changes from baseline in gene expression in the peripheral cells according to the intervention arm | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm | RNA from peripheral leukocytes will be isolated for the subsequent measurements of changes in gene expression of toll-like receptors, GLUT-4, C-peptide, resistin adn IL-6, and genes involved in telomere maintenance and oxidation |
Countries
Spain
Outcome results
None listed