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Insulin Resistance clinical trials

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NCT ID: NCT06205030 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Efficacy of NOSHINtrial in Diabetic Patients

NOSHIN
Start date: June 14, 2024
Phase: Phase 4
Study type: Interventional

The goal of this [Efficacy of a traditional anti-diabetic herbal drug with on glycemic, inflammatory, and oxidative stress parameters] is [investigate the level of HOMA-estimated insulin resistance as the primary outcome before and after 40 days in intervention and placebo groups] in [patients with type 2 diabetes]. The secondary outcomes of this study are the assessment of oxidative stress, inflammation biomarkers, other glycemic indices, hematopoietic status and lipid profile between the two groups before and after the intervention. also The food frequency questionnaire (FFQ) and the physical activity questionnaire (FAQ) are used to evaluate the effect of potential confounding factors. This study has the code of ethics IR.KMU.REC.1402.291 from Kerman University of Medical Sciences and this drug has the number 12/14484 from Iran Food and Drug Administration (IFDA).

NCT ID: NCT06203275 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

The G Protein-Coupled Receptor Kinase Type 2 Inhibitor Paroxetine as Adjunctive Therapy to Improve Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus

Start date: January 2024
Phase: Phase 3
Study type: Interventional

The aim of this study is to investigate the effect of GRK2 inhibitor paroxetine on insulin resistance in patients with type 2 diabetes mellitus.

NCT ID: NCT06193668 Recruiting - Clinical trials for Lipid-induced Insulin Resistance

Overfeeding Induced Fat-tissue Stimulation

OVID_FASTI
Start date: January 31, 2024
Phase: N/A
Study type: Interventional

Type 2 diabetes is the most common metabolic disease worldwide, characterized by hyperglycemia, decreased whole body insulin sensitivity, and white adipose tissue (WAT) dysfunction. A key factor in its development is chronic overnutrition, usually with a high-fat diet (HFD), leading to disturbances of glucose and lipid metabolism. However, the mechanism of short-term HFD-induced tissue-specific insulin resistance remains poorly understood. This project aims to further unravel the underlying mechanisms of short-term HFD overnutrition-mediated WAT insulin resistance. The model described here corresponds to a randomized, single- blinded parallel-grouped trial, consisting of two interventions: a macronutrient-balanced diet and or a hypercaloric diet over three weeks in order to investigate differences in interorgan fatty acid and glucose metabolism between the studied groups. Based on recent studies, the hypothesis is that 21-day hypercaloric HFD induces WAT insulin resistance via a diacylglycerol, novel protein kinase C-insulin receptor signaling model in both fasting and insulin-stimulated states.

NCT ID: NCT06180837 Recruiting - Type 2 Diabetes Clinical Trials

Effect of Sleep Extension on Ceramides in People With Overweight and Obesity

Start date: February 12, 2024
Phase: N/A
Study type: Interventional

The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

NCT ID: NCT06173765 Recruiting - Inflammation Clinical Trials

Understanding Dose Related Effects of Strawberry

STRW
Start date: August 31, 2022
Phase: N/A
Study type: Interventional

The proposed research is designed to extend previous research findings building on the knowledge of strawberries as fruits that support a healthy immune and vascular system. The proposed research leverages a recently funded proposal by the USDA to study in greater depth inflammation, glucoregulation and oxidative stress defense and their relation to improving endothelial function and insulin sensitivity. Before and after strawberry intake, blood samples will be collected for monocyte (immune cells and source of inflammatory cytokines) isolation and activation via changes in cellular NF-κB and Nrf-2 (key transcription factors of inflammation/oxidative stress defense) status along with products of their activation (ie., plasma cytokines). Because inflammation and oxidative stress impairs endothelial function and insulin sensitivity, acutely and chronically, investigators will also study changes in vascular and insulin sensitivity status, assessing changes in vascular adhesion molecules, endothelial responsiveness through flow mediated vasodilation (ie., FMD) and insulin sensitivity using the Liquid Meal Tolerance (LMTT) if intravenous glucose tolerance test (IVGTT) method cannot be used due to supply chain issues of sterile Dextrose. Glucoregulation will be assessed by placing a Continuous Glucose monitoring (CGM) machine (Dexcom-6) to participants for 10 days at the beginning and at the end of the study period of intervention. The study will be a randomized, double-blinded, 3-arm parallel, 4-week, dose-response study. Individuals with chronic low grade inflammation will be sought to test the anti-inflammation - vaso-relaxing - insulin sensitivity effects of strawberry.

NCT ID: NCT06167135 Recruiting - Obesity Clinical Trials

Polycystic Ovary Syndrome, Mitochondrial Dysfunction, Obesity, Insulin Resistance Infertility (POMODORI) Cohort

POMODORI
Start date: September 10, 2021
Phase:
Study type: Observational [Patient Registry]

Enrolling of 150 female patients of fertile age diagnosed with PCOS, insulin resistance, infertility, or mitochondrial disease, and the same number of age- and sex-matched controls are planned. During the research biomarkers already with mitochondrial dysfunction in the scientific literature and common mtDNA abnormalities (deletions, point mutations, copy number changes, etc.) are examined.

NCT ID: NCT06163768 Recruiting - Insulin Resistance Clinical Trials

Effects of Insulin Resistance in Non-diabetic Acute Coronary Syndrome Patients

Start date: December 31, 2023
Phase: N/A
Study type: Interventional

Effects of insulin resistance in non-diabetic acute coronary syndrome patients by the homeostasis model assessment index (HOMA2-IR)

NCT ID: NCT06163248 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 2

Chrono Nutrition and Insulin Resistance in Diabetes

Chrono
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to determine the effect of a chrono nutrition intervention compared with a usual dietary intervention on insulin resistance in individuals with type 2 diabetes with overweight or obesity over a 6-month period. The main question it aims to answer is: What is the effect of a chrono nutrition intervention compared to a standard intervention on insulin resistance in individuals with T2D (type 2 diabetes) with overweight or obesity over a 6-month period? Participants: - Will be asked to fast for 12 hours each day. During the fasting period, they may consume non-caloric beverages such as plain water, coffee, or unsweetened tea. - They will be asked to follow a dietary plan in which the total daily calorie intake will be calculated using indirect calorimetry, subtracting 500 calories from the total calorie amount. - The dietary plan will have the following macronutrient distribution: 40% carbohydrates (<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and <10% saturated). - The plan will consist of 3 meals: breakfast will account for 40% of the total calories. Dinner will include only 10% of the total grams of carbohydrates. - The order of food consumption should be: 1) vegetables, 2) proteins, 3) complex carbohydrates, and 4) simple carbohydrates (fruits). Researchers will compare the chrono nutrition strategy with a standard dietary intervention to see the effect in insulin resistance.

NCT ID: NCT06159543 Not yet recruiting - Inflammation Clinical Trials

The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes

Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effect of 12 weeks of 1.5 cups per day of fresh mango on glucose control, insulin resistance, lipids, inflammation, oxidation and body composition in individuals with prediabetes. The main questions it aims to answer are: - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of glycemic control including fasting glucose and HgbA1c? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on fasting blood insulin and insulin resistance (HOMA-IR)? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on lipids including LDL-cholesterol, total cholesterol, HDL-cholesterol and triglycerides? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on oxidative stress including oxidized LDL-cholesterol and 8-iso-PGF2-alpha? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on markers of inflammation including c-reactive protein, e-selectin, ICAM and VCAM? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on percent body fat, fat mass, and lean mass? Participants will be asked to: - Consume 1.5 cups of mango per day for 12 weeks, take a 4 week break, and then avoid consuming mangos for 12 weeks - Attend a prerandomization clinic prior to study - Attend three (3) clinics where blood will be drawn during weeks 0, 12, and 28 of the study - Attend eight (8) clinics where anthropometric measurements (height, weight, body composition) will be conducted and interaction with study clinicians will occur during weeks 0, 4, 8, 12, 16, 20, 24, and 28 of the study - Complete questionnaires and surveys in person and remotely, including six (6) 24-hour dietary recalls. Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in glycemic indicators, insulin resistance, lipids, inflammation, oxidation and body composition between the two time periods.

NCT ID: NCT06152068 Recruiting - Obesity, Adolescent Clinical Trials

Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents

CIMT
Start date: October 1, 2023
Phase:
Study type: Observational [Patient Registry]

Carotid intima-media thickness (CIMT) is a marker for detecting endothelium dysfunction, and has become a non-invasive method that is very useful in detecting and evaluating subclinical atherosclerosis in obese children and adolescents. This method is very useful in visually detecting and monitoring changes in the intima and its medial thickness, and can also evaluate changes within the arterial wall in the absence of localized plaque. Previous research that was conducted found an increase in CIMT diameter in 44 of 59 obese adolescents. Obesity has a risk of increasing the diameter of CIMT which carries the risk of atherosclerosis. Obesity accompanied by insulin resistance, and metabolic syndrome has a greater risk of atherosclerosis. Currently, the prevalence of obesity in adolescents is increasing. Interleukin 18 is a group of interleukin 1 whose levels increase in chronic inflammatory processes such as obesity, metabolic syndrome, and type 2 diabetes mellitus. IL-18 levels increase in obesity with increased CIMT. Assessment of cardiovascular risk in obese adolescents is still a challenge for health practitioners, to prevent cardiovascular complications in obese adolescents which can cause sudden death at a young age. It is necessary to assess changes in the cardiovascular system that can be identified early by knowing the CIMT diameter. However, there is no definite reference value so the CIMT can be used as a reference for the occurrence of subclinical atherosclerosis in obese adolescents. In the previous study, CIMT was not examined in non-obese adolescents, so the cut-off for CIMT in non-obese was not known. Therefore, we have the opportunity to research to determine the thickness of CIMT and determine the cut-off value of CIMT which is at risk of experiencing early atherosclerosis in the obese adolescent population.