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Insulin Sensitivity clinical trials

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NCT ID: NCT05154422 Completed - Obesity Clinical Trials

Effects of Regular Activity on Physiology Between Recreational Athletes of Different Body Fatness

Start date: October 23, 2020
Phase:
Study type: Observational

The popularity of marathons and endurance events has increased over the last few decades and, interestingly, the demographics of participants have also changed. From 1980 to 2002 the average race time to complete the marathon lengthened from ~3.5 hours to ~4.5 hours. Likewise, many endurance races include "Clydesdale" and "Athena" divisions for heavier weight male and female runners, respectively. As such, there has been an increase of overweight and obese participants in these races. For example, one study consisting of 250 runners determined, according to BMI, that approximately 15% and 31% of the female and male participants, respectively, were classified as overweight, with 31% and 33% classified as obese. Therefore, many recreational endurance athletes are overweight despite their high level of activity. On one hand, these data are positive as regular exercise reduces cardiovascular disease and all-cause mortality in overweight and obese populations. Yet, it is well documented in sedentary obese individuals that excess adiposity can lead to disturbances in adipocyte lipolysis and altered substrate utilization at rest and during exercise, and can decrease muscle quality. However, it is unknown if overweight individuals that exercise regularly have disrupted fat metabolism, circulating hormones, or muscle quality. No study has directly determined if differences exist in fat metabolism, circulating hormones, and muscle quality between overweight recreational female athletes and their lean counterparts when training status is equivalent. Therefore, the purpose of this investigation is to determine if differences in pre and post-exercise fat metabolism, circulating insulin and growth hormone, and muscle quality exist between active overweight individuals compared to active lean individuals with similar training history and who have regularly trained for and participated in endurance events within the last few years.

NCT ID: NCT05093517 Suspended - Type 2 Diabetes Clinical Trials

Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM

Start date: November 10, 2021
Phase: Early Phase 1
Study type: Interventional

With REMD's glucagon receptor antagonist, the study team propose to provide a comprehensive examination of the effect of elevated plasma glucagon concentrations in Type 2 Diabetes Mellitus (T2D) patients on: (i) glucose tolerance; (ii) insulin sensitivity in liver, muscle, and adipocytes; (iii) beta cell function; (iv) adipocyte inflammation.

NCT ID: NCT05065372 Recruiting - Clinical trials for Cardiovascular Diseases

MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes

MANATEE-T1D
Start date: July 1, 2022
Phase: Phase 1
Study type: Interventional

Diabetic kidney disease and cardiovascular disease remain the leading causes of morbidity and mortality in people with type 1 diabetes and are exacerbated with longer duration of diabetes and time outside goal glycemic range. Yet, type 1 diabetes is a complex disease with pathophysiology that extends beyond beta-cell injury and insulin deficiency to include insulin resistance and renal vascular resistance, factors that accelerate cardiovascular disease risk. We have shown that metformin improved peripheral insulin sensitivity and vascular stiffness in youth with type 1 diabetes on multiple daily insulin injections or standard insulin pumps. However, metformin's effect on kidney and endothelial outcomes, and the effects of type 1 diabetes technologies, with or without metformin, on any cardiovascular or kidney outcome, remains unknown. Automated insulin delivery systems combine an insulin pump, continuous glucose monitor, and control algorithm to modulate background insulin delivery and decrease peripheral insulin exposure while improving time in target range and reducing hypoglycemia. We hypothesize that automated insulin delivery systems, particularly when combined with metformin, may modulate renal vascular resistance and insulin sensitivity, thereby impacting cardiometabolic function. MANATEE-T1D is a randomized, double-blind, placebo-controlled trial of 4 months of metformin 2,000 mg daily in 40 youth aged 12-21 years with type 1 diabetes on automated insulin delivery systems vs. 20 control youth with type 1 diabetes on multiple daily injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor which will assess for changes in calculated renal vascular resistance and gold standard measures of whole-body and adipose insulin sensitivity, arterial stiffness, and endothelial function.

NCT ID: NCT04966351 Recruiting - Metabolic Disease Clinical Trials

Countermeasures to Circadian Misalignment

C2CM
Start date: July 7, 2021
Phase: N/A
Study type: Interventional

Insufficient sleep and circadian misalignment are independent risk factors for the development of obesity and diabetes, yet few strategies exist to counter metabolic impairments when these behaviors are unavoidable. This project will examine whether avoiding food intake during the biological night can mitigate the impact of circadian misalignment on metabolic homeostasis in adults during simulated night shift work. Findings from this study could identify a translatable strategy to minimize metabolic diseases in populations that include anyone working nonstandard hours such as police, paramedics, firefighters, military personnel, pilots, doctors and nurses, truck drivers, and individuals with sleep disorders.

NCT ID: NCT04924504 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Mechanisms Behind Severe Insulin Resistance During Pregnancy in Women With Glucose Metabolic Disorders (SIR-MET)

Start date: May 1, 2021
Phase:
Study type: Observational

The aim of this study is to describe the metabolic changes during pregnancy in women with type 2 diabetes or gestational diabetes in order to detect the pathophysiological mechanisms behind severe insulin resistance during pregnancy as well as the short- and long term consequences for mother and child. Included pathophysiological mechanisms potentially associated with severe insulin resistance are: Maternal hormonal, inflammatory and metabolic markers in the blood, as well as the level, content and bioactivity of exosomes and genetic variants associated with overweight and diabetes. In addition to the analysis on maternal blood, the same analysis will be performed on umbilical cord blood in order to determine the correlation between markers associated with insulin sensitivity in maternal and umbilical blood. Furthermore, fetal metabolic changes influence on fetal growth and development will be evaluated. Postpartum, the breast milk will also be examined for metabolic active substances that could influence the newborns growth and metabolism. Investigating one potential short-term consequence of diabetes during pregnancy, the association between insulin resistance and structural and functional changes in the placenta will be examined as well as the consequences of such changes on fetal growth and development. Investigating one potential long-term consequence of diabetes during pregnancy, the association between treatment with high doses of insulin during pregnancy and the future risk of developing cardiovascular diseases and heart failure will be examined.

NCT ID: NCT04872426 Completed - Insulin Sensitivity Clinical Trials

Ischemia-reperfusion Exercise Study

Start date: August 31, 2018
Phase: N/A
Study type: Interventional

The study investigates the relationship between activation of AMP-activated protein kinase (AMPK) in human skeletal muscle and the subsequent improvement in muscle insulin sensitivity for the stimulation of glucose uptake. This will be investigated in young healthy lean male subjects.

NCT ID: NCT04817787 Recruiting - Metabolic Syndrome Clinical Trials

Exercise Dose and Metformin for Vascular Health in Adults With Metabolic Syndrome

Start date: November 28, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Arterial disease is the leading cause of morbidity/mortality in Metabolic syndrome (MetS). This occurs early as evidenced by arterial dysfunction that, in turn, raises blood pressure and glucose. Health organizations recommend exercise in an intensity based manner to promote cardiovascular adaptation and prevent disease. Metformin is a common anti-diabetes medication that reduces future type 2 diabetes and cardiovascular risk. However, the optimal exercise dose to be combined with metformin for additive effects on vascular function is unknown. Based on the investigator's preliminary work, the overall hypothesis is that metformin blunts adaptation following high intensity exercise training (HiEx) by lowering mitochondrial derived oxidative stress signaling. The investigators further hypothesize that low intensity exercise (LoEx) training combined with metformin will promote additive effects on vascular function compared to LoEx or HiEx+metformin, and maintain/improve non-exercise physical activity patterns. In this double-blind trial, obese 30-60y MetS participants will be randomized to: 1) LoEx+placebo; 2) LoEx+metformin, 3) HiEx+placebo; or 4) HiEx+metformin for 16 weeks.

NCT ID: NCT04774081 Completed - Insulin Sensitivity Clinical Trials

Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study

CGM-PEPTIDE
Start date: February 8, 2021
Phase:
Study type: Observational

This study will determine whether the ratio between 24h C-peptide urinary excretion rate and average 24h circulating glucose represent a good correlate of what is measured by the gold standard, i.e. M (glucose disposal rate) from a euglycemic-hyperinsulinemic clamp

NCT ID: NCT04708535 Enrolling by invitation - Obesity Clinical Trials

Adaptive Immune Response in Visceral and Subcutaneous Fat: Role in Human Insulin Resistance

Start date: August 1, 2017
Phase:
Study type: Observational

The proposed study is designed to test the hypothesis that in human obesity, the balance of pro- and anti-inflammatory T cells in fat tissue is in fact related to macrophage phenotype and insulin resistance, and how it is related. This study is needed to confirm whether conclusions based on studies of visceral adipose tissue in mice are indeed applicable to humans. We also want to determine the relationship between insulin resistance/hyperinsulinemia and ability to lose weight in obese individuals.

NCT ID: NCT04662866 Recruiting - Insulin Sensitivity Clinical Trials

Effects of Glucose Lowering Agents in South Asian Women With Impaired Glucose Tolerance or Impaired Fasting Glucose

DIASA3
Start date: February 10, 2021
Phase: Phase 2
Study type: Interventional

This study will test the effect of four common oral anti-diabetic agents on hepatic insulin sensitivity in South Asian women with impaired glucose tolerance or impaired fasting glucose. In a 12-week, double-blind, randomized controlled intervention trial, the following drugs will be tested head-to-head: Metformin, Pioglitazone, Empagliflozin and Linagliptin. Additional, exploratory outcomes include whole body insulin sensitivity, insulin secretion and other markers of glucose and lipid metabolism, measured by the euglycemic clamp with stable isotope tracer dilution, indirect calorimetry and CT-measurements of abdominal adipose tissue compartment volumes and hepatic and pancreatic volume and attenuation. The study is part of the DIASA - DIAbetes in South Asians - Research Programme, which aims to find ways to improve both prevention and treatment of type 2 diabetes in people of South Asian ethnicity.