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Insulin Sensitivity clinical trials

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NCT ID: NCT05337098 Recruiting - Insulin Sensitivity Clinical Trials

Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes

Start date: April 18, 2023
Phase: N/A
Study type: Interventional

Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of sucralose, but not aspartame, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.

NCT ID: NCT05233722 Recruiting - Insulin Sensitivity Clinical Trials

mTOR as Mediator of Insulin Sensitivity Study

Start date: February 10, 2022
Phase: N/A
Study type: Interventional

The study investigates the role of mTOR in mediating enhancement of muscle insulin sensitivity following a single bout of exercise. This will be investigated in young healthy male subjects by administering the pharmacological mTOR inhibitor Rapamycin in a crossover blinded experimental setup known to enhance muscle insulin sensitivity following one-legged knee-extensor exercise.

NCT ID: NCT05195164 Recruiting - Blood Pressure Clinical Trials

The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women

Start date: March 22, 2021
Phase:
Study type: Observational

This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women.

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: 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: 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.

NCT ID: NCT04617405 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders.

HI-MET
Start date: January 11, 2021
Phase:
Study type: Observational

The first aim of this study is to describe maternal hormonal and inflammatory changes during pregnancy in women that differ metabolically (limited to women with type 2 diabetes, gestational diabetes and/or overweight). The second aim of this study is to examine maternal hormonal, inflammatory and metabolic factors associated with insulin sensitivity in human pregnancy.

NCT ID: NCT04596592 Recruiting - Insulin Sensitivity Clinical Trials

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

PUBERTY
Start date: February 15, 2021
Phase:
Study type: Observational

To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.