Treatment Trials

23 Clinical Trials for Various Conditions

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RECRUITING
The Movie Theater Study
Description

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).

TERMINATED
Effects of Arm Cycling and Leg Cycling on Postprandial Blood Glucose Levels in Healthy Persons
Description

The literature has shown that exercise is effective in decreasing blood glucose levels. However, it remains less clear if there is any difference between muscle groups regarding the glucose-lowering effects of exercise. The purpose of this study is to examine the differences in blood-glucose level changes in response to exercise that involves different muscle groups.

COMPLETED
Effect of Postprandial Hyperglycemia on Vasculature in Type 1 Diabetes and Healthy Adults
Description

To the investigator's knowledge, there are no data available in the current literature regarding the acute effects of postprandial hyperglycemia and insulin timing on myocardial perfusion in people with type 1 diabetes (T1D). Observational studies using CEU in type 2 diabetes demonstrate that postprandial hyperglycemia determines myocardial perfusion defects. The investigator hypothesizes that the combination of postprandial hyperglycemia and insulin increases pulse wave velocity (i.e., aortic stiffness) and myocardial vasoconstriction, thereby reducing myocardial perfusion in T1D when compared to healthy controls. Furthermore, the investigator hypothesizes in T1D that dosing insulin before meal intake will ameliorate these cardiovascular defects.

COMPLETED
Effect of Protein Intake on Post Prandial Hyperglycemia in Children and Adolescents With Type1 Diabetes Mellitus
Description

In type 1 Diabetes Mellitus, patients receive insulin doses if they consume specific amounts of carbohydrates. Currently, insulin is not being administered for consumption of protein although studies in adults show that consuming about 75 grams of protein causes elevation in post prandial glucose levels and might need insulin coverage. We are proposing that this amount is different for kids and it might vary based on weight, age, pubertal stage, HbA1C or other factors. This has not been studied in children before, and it will provide information about the amount of protein in the diet that can cause elevation in post prandial glucose.

TERMINATED
Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes
Description

Glucagon regulation and response in persons with T1D at the basal state and in response to various stimuli remains unclear. Dr. Philip Cryer has previously reported that, in T1D young adults with a course of the disease of 16+9 years, the absence of endogenous insulin secretion results in increased glucagon secretion after a mixed meal, concluding that endogenous insulin reciprocally regulates the alpha-cell glucagon secretion and also suggesting that glucagon dysregulation may play an important role in post-prandial hyperglycemia in T1D. Interestingly, recent research on human islets have shown that insulin inhibits counter-regulatory glucagon secretion by a paracrine effect mediated by SGLT2-dependent stimulation of somatostatin release. An important gap in our knowledge is whether the timing of prandial insulin doses affects the glucagon response to a hyperglycemic stimulus in patients with T1D who have undetectable C-peptide. Whether appropriately timed exogenous insulin can modify the glucagon response to glucose fluctuations has not been studied. As such, this pilot study aims to characterize the glucagon response to meal-time hyperglycemia and to compare the difference in glucagon secretion when mealtime bolus insulin is given before the meal versus after the meal with the objective of understanding factors that contribute to the peak post-prandial blood glucose and AUC of blood glucose after a mixed meal in this target population.

COMPLETED
Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
Description

The objective of this study is to formulate and validate a green tea confection (i.e. "gummy" candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. The central hypothesis is that a green tea confection will protect against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of this application will be assessed by developing a green tea-containing confection, examining its physiochemical properties and its inhibition of starch digestion, and then validating its vasoprotective activities in healthy humans by assessing its blood glucose-regulating activities.

COMPLETED
Individually Timed Stair Climbing and Descending to Lower Postprandial Glucose
Description

Effect of individually timed exercise to attenuate postprandial glucose excursions

COMPLETED
The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans
Description

The main objective of the current study is to investigate whether consumption of soluble fibers (isomaltodextrin \[IMD\], partially digestible maltodextrin) and RS4 starch will lower postprandial glycemia as well as postprandial insulin in human subjects with relatively high fasting blood glucose, when consumed with a specific amount of digestible carbohydrate (rice porridge). The primary outcome of the study is the effect of fibers on postprandial blood glucose, whereas the secondary outcome will be its effect on postprandial blood insulin.

COMPLETED
Effect of Feet and Calf Heating on Glucose Tolerance
Description

Determine the effect of feet and calf heating on glucose tolerance relative to thermoneutral control. Heat will be administered using hot water (40 degrees celsius).

COMPLETED
AVACEN Treatment Method and Postprandial Blood Glucose
Description

A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on postprandial blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject will use each of these three devices during the first hour of a 2-hour oral glucose tolerance test on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 2-hour oral glucose tolerance test.

COMPLETED
Comparison of Different Types of Resistant Starch
Description

This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.

COMPLETED
Glycemic Response of Whole Beans and Bean Products
Description

The main goal of this clinical trial is to learn if alpha-galactosidase (tradename Beano) changes in post-prandial (after-meal) blood glucose after eating whole cooked whole pulses or pulse-based pasta products in comparison to the same foods without alpha-galactosidase. Comparison of postprandial blood insulin and triglyceride levels, appetite, and gastrointestinal symptoms of flatulence, bloating, and stool changes will be evaluated by comparisons of the alpha-galactosidase and the pulse form (whole vs. pasta). In addition to blood glucose, such as flatulence and bloating, postprandial glucose, insulin, and appetite of individuals. The study design is a 4x4 crossover and the population is healthy volunteers aged 21-34 with normal glucose response and body weight. The primary hypothesis is that alpha-galactosidase will cause increased postprandial blood glucose for both whole and pasta pulse foods. The secondary hypothesis is that gastrointestinal symptoms will be less for both meals with the alpha-galactosidase. Other comparisons are exploratory. Participants will come in fasting for one morning per week and receive the food treatments in randomized order. Test measurements will be taken over a four hour period.

RECRUITING
Short, Simple, Exercise to Improve Circadian Dependent Postprandial Glycemic Responses
Description

The goal of this clinical trial is to test whether one minute of stair stepping at a comfortable pace can reduce blood sugar after meals. The main objectives of the study are: Compare continuously measured post-meal glucose after stair-stepping to control condition Compare continuously measured post-meal glucose after stair-stepping between meals Assess interaction between condition and meal to determine if the effect of stair-stepping on post-meal glucose depends on meal Participants will be in the study for 10 days and will be asked to: Wear a continuous glucose monitor over the course of the study Perform either one minute of comfortable pace stair stepping 15 min after each meal OR no exercise 1 hour after eating a meal on alternating days Perform a dietary recall every two days Perform no exercise within one hour after each meal on any day during the study Consume no calories within one hour after each meal during the study

COMPLETED
Emotion-Diet Interactions in Pregnancy
Description

This study will investigate how maternal emotional state following a controlled stress exposure in pregnancy influences blood glucose and insulin levels after eating a standardized meal, and whether the effects of emotional state on blood glucose and insulin is different after eating a healthy meal (low GI) compared to a less healthy meal (high GI).

COMPLETED
Evaluating the Acute Glycemic Response to Different Strategies of Breaking Up Sedentary Time
Description

This study aims to determine the most effective strategy of reducing sedentary behavior to improve health. Specifically, we aim to answer the following questions: (a) To determine if there is a significant difference in acute post-prandial glucose response between continuous sitting and two intermittent standing regimes (high frequency, low duration breaks (HFLD) and low frequency, high duration breaks (LFHD)). We hypothesize that intermittent standing (combined HFLD breaks and LFHD breaks regimes) will result in lower overall acute post-prandial glucose compared to continuous sitting. (b) To determine if there is a significant difference in acute post-prandial glucose response between two strategies to reduce sitting with standing (HFLD standing breaks vs. LFHD standing breaks). We hypothesize that the HFLD breaks condition will elicit lower acute post-prandial glucose level compared to the LFHD breaks condition. All eligible participants will be consented and subjected to all three study conditions: (i) Uninterrupted sitting, (ii) HFLD breaks, and (iii) LFHD breaks. The order at which participants were subjected to these conditions will be randomly determined and each condition were performed a week apart. Standardized meals (breakfast and lunch) will be provided during each lab visit and participants will be then be asked to perform their usual work activity using a sit-stand workstation in the lab. Depending on their assigned condition, the participants will be prompted to stand or sit for a given period of time. A continuous glucose monitor will be used to measure glucose response to the intervention while an activPAL device will be used to make sure that participants are compliant with the study protocol.

UNKNOWN
Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome
Description

This study is focused on assessing potential health benefits of daily consumption of potatoes, specifically its resistant starch content (i.e. nondigestible carbohydrate), on blood vessel and gut health function in adults with metabolic syndrome. It is expected that the daily consumption of potatoes for two weeks, within a diet that follows the Dietary Guidelines for Americans, will improve blood vessel function in association with decreasing gut permeability ("leaky gut") that results in the absorption of bacterial toxins that reside in the intestine. Outcomes will therefore support dietary recommendations for potatoes to support vascular and gastrointestinal health.

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.

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.

TERMINATED
Validation of Machine Learning Based Personalized Nutrition Algorithm to Reduce Postprandial Glycemic Excursions Among North American Individuals With Newly Diagnosed Type 2 Diabetes
Description

This is an initial validation study of the Personal Nutrition Project (PNP) algorithm in a North American population with recently diagnosed Type 2 Diabetes (T2D). This is a 2-stage, single-group feeding study in 20 individuals, including 10 participants managed with lifestyle alone, and 10 managed with lifestyle plus metformin.

Conditions
COMPLETED
Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Milk
Description

Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function and increase the risk of CVD. Greater intakes of dairy foods have been associated with a lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods in the diet that might increase CVD risk is unclear. The health benefits of dairy on heart health are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to further investigate dairy as a dietary strategy to reduce PPH and risk for CVD. The objective of this study is to define the extent to which dairy milk, and its whey and casein protein fractions, protect against postprandial vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.

Conditions
COMPLETED
Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Fat
Description

Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function and increase the risk of CVD. Greater intakes of dairy foods have been associated with a lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods in the diet that might increase CVD risk is unclear. Further controversial is the extent to which dietary fat derived from dairy foods regulate the risk of CVD. The health benefits of dairy on CVD risk are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to investigate full-fat containing dairy as a dietary strategy to reduce PPH and risk for heart disease. The objective of this project is to define the extent to which full-fat dairy milk compared to non-fat dairy milk protects against PPH-induced vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.

Conditions
COMPLETED
Cardioprotective Activities Of Whole Eggs On Vascular Endothelial Function In Prediabetic Adults
Description

Cardiovascular disease (CVD) is largely a lifestyle-related condition that is the #1 killer of adults in the United States. Our work is aimed at understanding how short-term increases in blood sugar, like those that accompany eating a meal, affect blood vessel function and the risk of CVD. This research is aimed at understanding how meals composed of eggs affect short-term increases in blood sugar from eating, which are connected with increased risk of CVD. In particular, the investigators are trying to identify a specific meal composed of either whole eggs, egg yolks, or egg whites, that best reduces acute increases in blood sugar brought on by meals that consist of majority carbohydrate. At the same time, the investigators are trying to explore the protective affects that eggs may have on blood vessel function and the reduction of CVD risk.

COMPLETED
Investigating the Use of Quercetin on Glucose Absorption in Obesity, and Obesity With Type 2 Diabetes
Description

Quercetin is a compound naturally found in various foods. It may have some role in the treatment of obesity and diabetes. The purpose of this study is to investigate research volunteers with obesity or obesity with type 2 diabetes to determine whether quercetin affects the way glucose is absorbed by the body. Thirty two participants aged 19 to 65 who are considered to be medically obese or obese with type 2 diabetes will be enrolled in this study. Before the onset of treatment, they will undergo a medical history, physical exam, blood work, and urinalysis. During the study, participants will be given an oral glucose tolerance test three times; during these tests they will receive 1 or 2 grams of quercetin, or placebo. Researchers will collect blood samples and analyze the effect of the treatment on blood glucose.

Conditions