Treatment Trials

39 Clinical Trials for Various Conditions

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RECRUITING
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
Description

This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.

RECRUITING
Effect of Zinc on Glucose Homeostasis
Description

The purpose of this investigation is to evaluate the impact of zinc supplementation on fasting glucose levels, hemoglobin A1c (HbA1c), and other indices of glucose homeostasis in individuals with prediabetes. The investigators hypothesize that prediabetic subjects receiving zinc will demonstrate a greater decrease in HbA1c and blood glucose compared to prediabetic subjects receiving placebo. Specific Aim: Conduct a prospective, double-blind randomized clinical trial comparing the effects of 12 months of zinc supplementation (zinc gluconate 30 milligram \[mg\] per day) versus placebo on glucose homeostasis. Based upon expected effect size and power calculations, and anticipating a 20% drop-out rate, the investigators will study 200 prediabetic subjects (100 per group) using a 1:1 randomization design. HbA1c, fasting plasma glucose, and other measures will be obtained at 0, 6, and 12 months and will be compared between zinc supplementation and placebo groups.

COMPLETED
A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes
Description

This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.

Conditions
RECRUITING
Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes
Description

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 saccharin, but not acesulfame potassium, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.

ACTIVE_NOT_RECRUITING
Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis
Description

Advancing age is associated with gut dysbiosis, low-grade chronic inflammation, progressive insulin resistance, and increased risk of type 2 diabetes (T2D). Prediabetes is present in 45-50% of middle-aged/older adults, and declines in glucose tolerance are evident in the third or fourth decade of life. Thus, there is an urgent need to identify new approaches for the prevention of type 2 diabetes among middle-aged adults. Observational research has linked intake of ultra-processed foods (UPF), which comprise \~60% of total energy intake in US adults, with increased risk of T2D. Ex vivo and animal research suggests that components of UPF alter gut microbiota composition and initiate a cascade of events leading to intestinal inflammation and impaired glycemic control. Whether mid-life adults (aged 45-65 yrs) are susceptible to the adverse impact of UPF consumption on glucose homeostasis is unknown. The overall objective of this study is to establish proof-of-concept for an impairment in glucose homeostasis following increases in UPF consumption in mid-life adults, in order to conduct a larger, more comprehensive and mechanistic trial in the future. In addition, changes in gut microbial composition and function, intestinal inflammation and permeability, serum endotoxin concentrations, and inflammatory cytokines as potential mechanisms by which UPF consumption influences glucose homeostasis will be investigated.

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

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.

ACTIVE_NOT_RECRUITING
Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
Description

The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.

Conditions
TERMINATED
Glucose Homeostasis in Pseudohypoparathyroidism
Description

It is increasingly recognized that Pseudohypoparathyroidism type 1A (PHP1A) is associated with an increased risk of type 2 diabetes but the mechanism is unknown. In this pilot study we will assess β-cell function in patients with PHP1A and pseudopseudohypoparathyroidism PPHP.

COMPLETED
Effects of Simulated Passive Jogging Device on Glucose Homeostasis, Muscle Strength and Endurance
Description

Physical Inactivity and excessive sedentary behavior are risk factors for diabetes and cardiovascular disease. Movement is important for overall health. This study will assess the validity and usefulness of low risk, non-invasive wellness device, the Gentle Jogger® (GJ) that passively simulates the physical activities of jogging. The study will evaluate whether or not use of GJ modifies glycemic control and muscle strength in subjects who are known to be diabetic and those who are not. The study volunteers are subjects between the ages of 25-80yr.

WITHDRAWN
Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes - Main Study
Description

Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.

WITHDRAWN
Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study
Description

Investigators will test the hypothesis that chronic restoration of vagal nerve activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American Women compared to white women.

COMPLETED
Kisspeptin Influence on Glucose Homeostasis
Description

The goal of this study is to learn about how a naturally occurring hormone called kisspeptin affects blood sugar and insulin levels.

COMPLETED
Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes
Description

Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.

COMPLETED
Arsenic, Disordered Glucose Homeostasis and Atherosclerosis
Description

Investigators will recruit 250 subjects; Group A will consist of 100 prediabetic patients with an A1c of 5.7%-6.4%. Group B will consist of 100 patients with uncontrolled T2D defined as either a) an A1c of 6.5%-7.9% without diabetes medications or b) an A1c ≥ 8.0% with or without diabetes medications. Group C will include 50 participants without T2D or known cardiovascular disease to serve as control comparisons.

COMPLETED
The Impact of Low-fat and Full-fat Dairy Consumption on Glucose Homeostasis (DAIRY Study)
Description

This randomized controlled feeding trial aims to determine whether the consumption of different amounts and types of dairy products affects blood sugar regulation and cardiometabolic health in men and women with the metabolic syndrome.

COMPLETED
Efficacy of Vitamin D Therapy on Glucose Homeostasis in Obese Adolescents
Description

The purpose of this study is to see whether giving a Vitamin D supplement to vitamin D deficient obese children and adolescents will decrease the risk of getting diabetes (Disease in which the person has high blood sugar). The number of vitamin D deficiency in U.S. children and teenagers has grown dramatically over the past 30 years. There are some reports suggesting that vitamin D supplementation in adults with pre diabetes (blood glucose higher than normal) and vitamin D treatment will prevent diabetes.

COMPLETED
Racial Differences in Vagal Control of Glucose Homeostasis
Description

The investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore PNS activity and reduce oxidation in AAW compared to whites.

Conditions
COMPLETED
To Define the Role of GLP-1 for Improving Glucose Homeostasis in Humans Following Gastric Bypass Surgery
Description

There is a marked and long-lasting improvement in glucose homeostasis that follows Roux-en-y gastric bypass surgery (RYGB) in humans. This improvement has been attributed in large part to an intestinal hormone, called GLP-1, that is released into the circulation immediately after eating. The purpose of this study is to determine if GLP-1 mediates the beneficial effects of RYGB surgery on glucose homeostasis in humans.

COMPLETED
Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis
Description

The objective of the present proposal is to compare the clinical, endocrine and metabolic effects of therapy with combination saxagliptin and metformin to saxagliptin and metformin monotherapy in women with PCOS and prediabetic hyperglycemia (IFG, IGT or IFG/IGT). Saxagliptin is an oral dipeptidyl peptidase IV (DPP-4) inhibitor whose mechanism of action is to prolong the duration of blood glucagon-like peptide (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) levels by inhibiting their degradation and thereby augmenting insulin secretion. This study will serve as a pilot investigation to open perspectives for future studies to explore the potential of combining anti-diabetic drugs with different mechanisms of action in in patients with PCOS and impaired glucose regulation (IGR), especially ones for whom standard treatment with metformin is less effective.

TERMINATED
Sleep Effectiveness and Insulin and Glucose Homeostasis
Description

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.

COMPLETED
The Effects of Bethanechol on Glucose Homeostasis
Description

Xenin-25 and glucose-dependent insulinotropic polypeptide (GIP) are hormones produced in the intestine that are released into the blood immediately after ingestion of a meal. Together, these 2 hormones increase insulin release and reduce blood glucose levels. Xenin-25 works by increasing acetylcholine release in pancreatic islets. This study will determine if a Bethanechol, a drug that is similar to acetylcholine, also increases insulin release and reduces blood glucose levels after ingestion of a mixed meal.

TERMINATED
Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis
Description

The purpose of this study is to determine the effect of chronic PDE5 inhibitor therapy on glucose metabolism in persons with prediabetes.

COMPLETED
Effects of a Food Preservative on Glucose Homeostasis
Description

The investigators propose to examine the effects of the common food preservative sodium benzoate on blood glucose and related hormones and metabolites. If an effect is demonstrated, patients with increased diabetes risk could be counseled to avoid this preservative.

Conditions
COMPLETED
Glucose Homeostasis Pre and Post Bariatric Surgery
Description

The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then you are responsible for payment of the surgical process. We are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on metabolic function.

Conditions
TERMINATED
Effects of Novel Fiber on Glucose Homeostasis in Individuals at Risk for Diabetes
Description

This study will critically evaluate the effects of a novel dietary fiber administered to subjects at high risk for developing diabetes to determine if this intervention will improve insulin sensitivity compared to control product administration and, thus, decrease risk for developing diabetes. The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening) compared to consumption of the control product.

COMPLETED
Aldosterone and Glucose Homeostasis
Description

Determine the effect of aldosterone on how the body handles glucose (sugar).

COMPLETED
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome
Description

The purpose of this study is to learn more about the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in polycystic ovary syndrome (PCOS) patients. The hypothesis is that a diet rich in these foods will improve insulin resistance in women with PCOS.

COMPLETED
The Role of Glucocorticoid Receptor SNPs in Receptor Function and Metabolic Disease
Description

Background: - Glucocorticoids are primary stress response hormones released from the adrenal gland when an individual is under stress. Chronic or ongoing elevation of these hormones due to prolonged stress or medical treatments can have numerous harmful effects. Researchers are interested in learning more about how these hormones affect cell growth, development, and death. To study glucocorticoid hormones, researchers plan to use the medication dexamethasone, which affects the parts of cells that respond to glucocorticoid hormones. Objectives: - To study glucocorticoid stress hormones in healthy individuals before and after receiving dexamethasone. Eligibility: * Healthy individuals at least 18 years of age. * Participants must not be using certain medications that may affect the dexamethasone test, including hormonal contraception, steroid-based drugs, and some antidepressants. Design: * This study will require an initial screening visit and a second study visit. The visits are estimated to require about 1 to 2 hours of participation over a period of up to 14 days. * Participants will be screened at visit 1 with a full physical examination and medical history, and an initial blood sample for testing. * For visit 2, participants will be asked to abstain from all food and drinks except for water for 12 hours before the appointment, and will take one tablet of dexamethasone 9 hours before the appointment. * Participants will have a second blood sample taken during visit 2, and will receive a snack after the blood is drawn.

TERMINATED
Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1)
Description

This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a naturally occurring hormone) on insulin release and to examine whether there is extra insulin release when GLP-1 is not allowed to be rapidly inactivated.

COMPLETED
Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Description

The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.