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Hyperinsulinemia clinical trials

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NCT ID: NCT06444984 Recruiting - Hyperinsulinemia Clinical Trials

The Movie Theater Study

Start date: March 24, 2024
Phase: N/A
Study type: Interventional

Increasing attention has been paid to meals with unusual characteristics that are consumed on a semi-regular basis (e.g., "tailgating," pizza buffets). The purpose of this study is to describe the acute cardiometabolic effects of a cinema-style meal rich in refined sugar, total carbohydrate, and moderate in fat (i.e., soda, popcorn, candy).

NCT ID: NCT05854251 Recruiting - PreDiabetes Clinical Trials

Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β

Hyper-PreDIL
Start date: June 15, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to test whether postprandial insulin secretion in subjects with prediabetes is mediated by Interleukin-1β and may be influenced by administration of the medicinal product anakinra (Kineret®). The main question it aims to answer is whether there is a difference in insulin secretion following a standardized mixed-meal test under anakinra compared to placebo.

NCT ID: NCT05729282 Recruiting - Insulin Resistance Clinical Trials

Glycemic Effect of Diazoxide in NAFLD

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to compare a two-week course of diazoxide (at two different doses) and placebo in people with overweight/obesity and insulin resistance (IR) with, or at high risk for, non-alcoholic fatty liver disease (NAFLD). The main questions it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects parameters of glucose and lipid metabolism (how people with IR and NAFLD respond to lowering high insulin levels so that the investigators can see what happens to how the liver handles fat and sugar). Participants will: - Take 27 doses of diazoxide (at 1 mg per kg of body weight per dose [mpk] or 2 mpk) or of placebo, over 14 days - Take 32 doses of heavy (deuterated) water (50 mL each) over 14 days - Have blood drawn and saliva collected after an overnight fast on four mornings over the two-week study period - Consume their total calculated daily caloric needs as divided into three meals per day - Wear a continuous glucose monitor for the two-week study period Researchers will compare fasting blood tests at intervals during the study period in participants randomized (like the flip of a coin) to diazoxide 1 mpk, diazoxide 2 mpk, or placebo, to see how the drug treatment affects plasma glucose, serum insulin, and serum lipid parameters (triglycerides, free fatty acids, and apolipoprotein B). They will also consume heavy (deuterated) water to assess de novo lipogenesis (building of new fatty acids by the liver).

NCT ID: NCT05724134 Recruiting - Obesity Clinical Trials

Pancreatic Clamp in NAFLD

Start date: August 29, 2023
Phase: Phase 1
Study type: Interventional

This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance [HOMA-IR] score >=2.73), and with evidence of, or clinically judged to be at high risk for, uncomplicated non-alcoholic fatty liver disease (NAFLD). Participants will undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.

NCT ID: NCT05126199 Recruiting - Insulin Resistance Clinical Trials

Time-restricted Eating to Improve Metabolic Abnormalities in Polycystic Ovarian Syndrome

TimeMAP
Start date: May 5, 2021
Phase: N/A
Study type: Interventional

Polycystic ovarian syndrome (PCOS) is associated with metabolic symptoms such as hyperinsulinemia. Time-restricted eating may reduce serum insulin and improve insulin resistance in patients with PCOS. Currently, there are few studies investigating time-restricted eating in patients with PCOS. The investigators plan to test the feasibility of time-restricted eating in the management of PCOS by means of a real-world clinical intervention. The investigators will determine if an 18:6 eating protocol reduces insulin levels by means of a randomised controlled crossover trial.

NCT ID: NCT04309071 Recruiting - Insulin Resistance Clinical Trials

Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

Start date: January 4, 2019
Phase: N/A
Study type: Interventional

Recent evidence suggests that hyperinsulinemia (i.e., elevated insulin levels) is the primary causative factor in obesity. Insulin promotes fat storage and prevents fat breakdown, suggesting that weight loss would be optimized if insulin levels are managed and kept low. Understanding how different foods impact insulin levels could therefore aid in personalized weight loss (or weight maintenance) advice. It has been shown that salivary insulin can track plasma insulin following different meals and can delineate between lean and obese people. Thus, it was suggested that salivary insulin could be a potential surrogate for plasma insulin. The purpose of this study is to measure fasting saliva insulin, and salivary insulin responses to a standardized meal tolerance test in individuals with different body mass index (BMI).