An interventional study of Pistachios and control diet in Type 2 Diabetes Mellitus, sponsored by Institut Investigacio Sanitaria Pere Virgili. Completed at 1 site in Spain. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Institut Investigacio Sanitaria Pere Virgili · Not applicable, Interventional, and Treatment
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.
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:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Institut Investigacio Sanitaria Pere Virgili is the lead sponsor of 35 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins)
Other: control diet
Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein)
Dietary Supplement: Pistachios
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.
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.
Changes from baseline in circulating levels of glucose and insulin according to the intervention arm
Measurement of circulating glucose and insulin levels and cellular glucose uptake
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm
Cpeptide, resistin, IL-6, IL-18, Ghrelin, leptin, adiponectin, GLP-1 and oxidized LDL will be measured.
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Changes from baseline in haemostatic parameters according to the intervention arm
Tissue factor, fibrinogen, PAI-1, vWF will be measured.
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Changes from baseline in HL and LDL size according to the intervention arm
Plasmi lipoprotein size will be measured by polycacrylamide gradient gel electrophoresis
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Changes in advanced glycation end products according to the intervention arm
Advanced glycation end products and soluble receptor of advanced glycation-end produtcs will be measured
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Changes from baseline in gene expression in the peripheral cells according to the 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
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Changes from baseline in cellular glucose uptake according to the intervention arm
Glucose uptake and GLUT4 protein levels will be assessed in peripheral leukocytes
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Changes from baseline in platelet function according to the intervention arm
Platelet number, mean platelet volume and platelet factor 4 in blood, and urinary levels of 11-dehydro-thromboxane B2 will be assessed.
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Changes from baseline in telomeric length of leukocytes (LTL)
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.
Time frame: 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.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Investigacio Sanitaria Pere Virgili