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Prediabetic State clinical trials

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NCT ID: NCT03844646 Terminated - Weight Loss Clinical Trials

Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes.

NCT ID: NCT03083600 Terminated - PreDiabetes Clinical Trials

Effect of Protein Hydrolysates on HbA1c Levels in Pre-diabetics

Start date: May 22, 2017
Phase: N/A
Study type: Interventional

To evaluate the effectiveness of three different daily doses of plant protein hydrolysates versus placebo, when consumed over a 12-week period, at reducing and maintaining glycated haemoglobin (HbA1c) levels in a pre-diabetic population (otherwise healthy subjects with impaired glucose metabolism). To evaluate the effectiveness of three different daily doses of pea or rice protein hydrolysates versus placebo, when consumed over a 12-week period on: post-prandial glucose/insulin levels (oral glucose tolerance test, fructosamine levels, fasting plasma glucose levels, vital signs, physical examinations, weight and blood pressure.

NCT ID: NCT02730962 Terminated - Pre-Diabetes Clinical Trials

Interventional Bioremediation of Microbiota in Metabolic Syndrome

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether changing the microbial composition in the colon can improve metabolism of sugar in people who are on the verge of developing diabetes (pre-diabetics). Study participants will undergo a fecal microbiota transplantation (FMT) using material from lean donors, as well as a series of tests prior to and after the transplant. The investigators will examine any changes in fecal bacterial composition associated with FMT and determine if any observed changes have an influence on blood sugar metabolism.

NCT ID: NCT02631148 Terminated - Obesity Clinical Trials

Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.

MAST
Start date: January 2016
Phase: Phase 2
Study type: Interventional

In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether sleep extension and nightly melatonin supplementation in the community is a feasible intervention with a beneficial effect on the following chronic kidney disease (CKD) risk factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured by 24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance and β-cell response to a mixed meal protocol.

NCT ID: NCT02393573 Terminated - Insulin Resistance Clinical Trials

Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism

Start date: November 2015
Phase: N/A
Study type: Interventional

Major surgery results in a stress- induced catabolic response, marked by post-operative insulin resistance, hyperglycemia and loss of body protein, which is associated with increased morbidity, mortality and adverse outcomes. There has been a great deal of research on different approaches to optimize post-operative insulin sensitivity including hormonal and nutritional interventions, minimally invasive surgical techniques and epidural anesthesia. However, the correlation between insulin resistance and body protein loss is not well understood. Metformin is the most widely used insulin sensitizing and blood glucose-lowering drug in treatment of type 2 diabetic patients. This study will: 1) estimate the correlation between insulin resistance and body protein loss in pre-diabetic lung/colorectal resection patients; 2) investigate whether the post-operative metabolic state can be improved by the pre-operative administration of metformin; and assess the impact of metformin on surgical complications and hospital length of stay. The results of this study will provide insight into the relationship between insulin resistance and post-operative adverse events and potentially suggest a novel approach to improve outcomes using Metformin, a drug already in wide clinical use.

NCT ID: NCT02387164 Terminated - Clinical trials for Diabetes Mellitus, Type 1

Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies

DiAPREV-IT2
Start date: March 9, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate if immune-tolerance with Alum-formulated GAD (Diamyd), in combination with high dose Vitamin D3, may delay or stop the autoimmune process leading to clinical type 1 diabetes in non-diabetic children with ongoing beta-cell autoimmunity as indicated by positive islet autoantibodies.

NCT ID: NCT02188823 Terminated - Prediabetes Clinical Trials

Examining the Effects of Diet on Health in Prediabetes With an Online Program

Start date: July 2014
Phase: N/A
Study type: Interventional

The study is a pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a clinical trial assessing a programs to help people manage prediabetes and lose weight with a low-carbohydrate diet (LC) along with information about positive affect, mindful eating strategies, exercise, and sleep.

NCT ID: NCT01977417 Terminated - Prediabetes Clinical Trials

Inflammation Inhibition in Prediabetic Humans

INCITE
Start date: November 2012
Phase: Phase 2
Study type: Interventional

Prediabetes, characterized by elevated fasting blood sugar or exaggerated blood sugar response to sugar ingestion, effects over 79 million adult Americans and is a precursor to the development of Type 2 diabetes. Importantly, approximately 42% of Iowans (950,000) have diabetes and 32% (670,000) have prediabetes with the majority of those with prediabetes going undiagnosed. Adults with prediabetes demonstrate early signs of cardiovascular and nervous system abnormalities and are at high risk for developing overt diabetes unless aggressive lifestyle (weight loss, exercise) or pharmacological interventions are employed. Interestingly, data in recent years has linked obesity and diabetes to chronic inflammation of the blood vessels and brain areas that regulate blood pressure. Therefore, the current study will test whether a commonly used aspirin-like anti-inflammatory drug called salsalate, will improve blood vessel health and nervous system dysfunction in adults with prediabetes. Eligible subjects will have measurements of blood pressure, blood vessel function in the arms and eyes, assessments of nerve activity, and blood samples taken before and after 4 weeks of ingesting an FDA approved aspirin-like drug called salsalate. The study is important because it will identify a potentially new pharmacological strategy to treat vascular and nervous system abnormalities in overweight and obese adults with early stage type 2 diabetes using an inexpensive, generically available drug with an excellent safety record that has been used for decades to treat chronic inflammatory conditions such as rheumatoid arthritis. If proven effective, this will provide preliminary support for the concept of targeting inflammation as a new clinical approach to treating early diabetes related complications. Furthermore, the current pilot study will provide support for developing a larger clinical trial using salsalate that could potentially then be extended to patients with type 2 diabetes and cardiovascular disease, as well as lead to the development of new anti-inflammatory agents with greater specificity for selective inflammatory pathways.

NCT ID: NCT01941277 Terminated - Prediabetic State Clinical Trials

Effect of Exercise on Insulin Resistance

EFFORT
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR) in subjects who do not routinely exercise and who are at risk of developing diabetes (prediabetes). It is estimated that approximately 30-90 people will participate in this study at three study sites in the United States and United Kingdom.

NCT ID: NCT01887691 Terminated - Diabetes Clinical Trials

Sleep Effectiveness and Insulin and Glucose Homeostasis

Start date: October 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the influence of sleep effectiveness on glucose and insulin metabolism in health and disease (prediabetes and type two diabetes). We will monitor sleep effectiveness using the sleep spectrogram, obtain serial nocturnal blood glucose and insulin measurements, and assess the impact of pharmacologic enhancement [using eszopiclone (Lunesta), a medication that promotes stable sleep)] on glucose and insulin homeostasis. We hypothesize that 1: Effective sleep is associated with enhanced insulin sensitivity, relative to ineffective sleep states, and 2: Enhancing sleep effectiveness using eszopiclone (Lunesta) improves 24-hour glucose metabolism in prediabetics and diabetics compared to baseline.