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Metabolic Diseases clinical trials

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NCT ID: NCT04132830 Recruiting - Clinical trials for HIV-exposed Uninfected

HIV Exposure In Utero and Metabolic Disease Risk in HIV-Negative Young Adults

HIV HEREDITY
Start date: October 1, 2019
Phase:
Study type: Observational

Globally, over 1 million babies are born to mothers with HIV each year. With the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected (HEU). A growing literature suggests that in utero HIV exposure - even in the absence of subsequent infection - may be associated with adverse health outcomes in infancy and childhood. However, there is little information about the long-term health implications of in utero HIV exposure later in life, such as into adulthood. In this study, for the first time, we seek to prospectively evaluate metabolic and immune indices among HEU young adults as compared to well-matched HIV-unexposed uninfected controls. This study serves as a necessary first step toward optimizing clinical care for this expanding and aging HEU population, including the implementation of novel screening and prevention strategies.

NCT ID: NCT04128488 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Effects of Gender-Affirming Hormone Therapy Among Transgender Women

Start date: November 1, 2019
Phase:
Study type: Observational

In this study, investigators plan to evaluate the cardiometabolic effects of initiating gender-affirming hormone therapy among transgender women with and without HIV. As part of this study, participants will undergo cardiovascular and metabolic phenotyping within 3 months of starting and after 12 months of gender-affirming hormone therapy. Cardiovascular phenotyping will include cardiac MRI/MRS imaging to evaluate cardiac function and structure. Metabolic phenotyping will include oral glucose tolerance testing, abdominal MR imaging to evaluate visceral adiposity, and whole body, lumbar, and hip DEXA imaging to evaluate fat and lean body mass as well as bone mineral density, respectively. Traditional markers of CVD risk as well as immune, hormonal, and coagulation parameters will also be assessed longitudinally.

NCT ID: NCT04125602 Completed - Clinical trials for Postprandial Hyperglycemia

Westlake N-of-1 Trials for Macronutrient Intake

WE-MACNUTR
Start date: October 20, 2019
Phase: N/A
Study type: Interventional

This is a dietary intervention study in students and staff of Westlake University, which is designed to provide evidence in support of N-of-1 methods as an approach to advance personalized nutrition. The primary aim is using a series of N-of-1 trials to determine the impacts of a high fat, low carbohydrate diet (HF-LC) on glucose metabolism and gut microbiota in subjects versus a low fat, high carbohydrate diet (LF-HC) at both the individual and group level.

NCT ID: NCT04122209 Recruiting - Weight Loss Clinical Trials

Does the Timing of When High Intensity Intermittent Exercise is Undertaken Matter?

HIIE
Start date: October 16, 2019
Phase: N/A
Study type: Interventional

The participants will visit the laboratory on 3 occasions, once for a preliminary visit and a further two occasions to complete experimental trials in a randomised order. The experimental trials will consist of cycling under two conditions; HIIE-First followed by Continuous (Trial-A) or Continuous-First followed by HIIE (Trial-B). Participants will be asked to standardise their diet for 24-hours and complete an overnight fast prior to visiting the laboratory. Participants will then complete 60-min of cycling split throughout the day into two 30-min bouts, HIIE or continuous cycling before breakfast followed by a 3.5 hour rest period before completing their remaining 30-min HIIE or Continuous cycling before lunch. Each experimental trail will last approximately 8 hours and begin at 08:00am. Throughout the trial measurements of subjective feelings of appetite, gastric emptying rate, substrate utilisation and regular blood samples will be taken. Post-trial nutritional and well-being questionnaires will be collected at 24-h post. Study hypothesis 1. The order in which continuous and HIIE is undertaken will result in differences in gastric emptying rate after ingesting a semi-sold lunch? 2. Depending on which mode of exercise is undertaken first will result in different gastrointestinal hormone responses, metabolic responses and appetite responses throughout the trial day? 3. Will the order in which different modes of exercise, undertaken within the same day effect nutritional intake and well-being 24-h after both exercise bout have been completed? 4. Is substrate oxidation effected by the order in which multiple exercise bout of different modes are undertaken within the same day.

NCT ID: NCT04116203 Suspended - Clinical trials for Polycystic Ovary Syndrome

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

PCOS
Start date: June 30, 2016
Phase: Phase 1
Study type: Interventional

The primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.

NCT ID: NCT04109586 Recruiting - Obesity Clinical Trials

Diet and Fat Mass After Traumatic Spinal Cord Injury

Start date: September 15, 2019
Phase: N/A
Study type: Interventional

This is a randomized clinical controlled trial (RCT) to investigate the impact of a personalized nutritional intervention on functional and clinical outcomes the first year after traumatic spinal cord injury. The long term goal is to prevent gain of body fat mass and obesity.

NCT ID: NCT04106570 Terminated - Obesity Clinical Trials

Neuromuscular Plasticity in Response to Obesity: Effects of Mechanical Overload, Metabolic Disorders and Age

PLANEUROB
Start date: December 2, 2019
Phase: N/A
Study type: Interventional

Obese people suffer from significant functional limitations, which affect their quality of life and limit their physical activity level. Functional abilities are largely determined by neuromuscular properties, i.e the ability to produce a torque or a power, and fatigability, i.e the ability to maintain a high level of torque production during repeated contractions. Our previous studies on "healthy" obese adolescents (i.e without inflammation or metabolic disorder) suggests that obesity has positive effects on the neural and muscular factors responsible for torque production, with chronic overload acting as a strength training . However, this high torque level is associated with higher fatigability. These results are in contrast with the data obtained on adult obese patients (young and elderly), in whom torque production and fatigability appear to be more impaired, probably due to the development of metabolic disorders associated with obesity (inflammation, insulin resistance and lipid infiltration in muscle) and aging. The respective effects of mechanical overload, metabolic disorders (insulin resistance and lipid infiltration) and aging on neural and muscular factors of torque production and neuromuscular fatigue etiology are not currently known in young adult obese of elderly. Their relationship to the clinical symptoms of mobility troubles is also unknown. However, this knowledge is crucial for designing physical activity programs tailored and adapted to the level of metabolic impairment and age of obese patients. The hypothesis is that mechanical overload associated with obesity has positive effects on torque production in the absence of metabolic alteration and the effect of aging but negative effects on fatigability, mainly due to muscular factors; the insulin resistance increases peripheral fatigue (due to an alteration in the excitability of the sarcolemma during fatiguing exercise), central fatigue, and slows recovery; the development of inflammation and lipid infiltration, which are more pronounced in obese subjects, further affect torque production through inhibition of the nervous control and alteration of contractile properties and muscle architecture, all these phenomena leading to a decrease in torque production and increased fatigability, cumulating with the effects of the ageing (sarcopenia).

NCT ID: NCT04103424 Completed - Insulin Resistance Clinical Trials

Mitochondrial Remodeling After Exercise

Start date: August 23, 2019
Phase: N/A
Study type: Interventional

Regulation of mitochondrial health in overweight and obese individuals may be impaired. The purpose of this study is to identify impairments in regulation of mitochondrial health within skeletal muscle and to determine if short-term exercise training (2-weeks) can reverse such impairments. The investigator's hypothesis is that pathways that serve to degrade poorly functioning mitochondria in overweight and obese individuals are down-regulated, but that short-term exercise training can restore these pathways to improve skeletal muscle mitochondrial function.

NCT ID: NCT04098549 Completed - Type 1 Diabetes Clinical Trials

The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes

RaSlo-19
Start date: September 12, 2019
Phase: N/A
Study type: Interventional

In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential. Previously, a number of potential influencing factors of hepatic glucose production have been investigated, including insulin-on-board, low carbohydrate diet, preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production. Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of fall in blood glucose influences the following stimulation of hepatic glucose response. However, the rate of fall in blood glucose is highly related to insulin levels, which may explain those findings. Thus, in this study the investigators want to examine whether the different rates of fall in blood glucose with similar insulin levels on board affect the hepatic glucose response in individuals with type 1 diabetes. In the study, which will be conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits. On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose production will be stimulated using low-dose glucagon. The study days are divided into four phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and 4) post-glucagon administration phase. This design will allow the investigators to examine whether differences in hepatic glucose response exist depending on preceding rate of fall in blood glucose. We hypothesize that the rate of fall in blood glucose does not affect the hepatic glucose production.

NCT ID: NCT04096313 Completed - Diabetes Mellitus Clinical Trials

Evaluation of the Analytical Performance of ALLEGRO™ Instrument

Start date: March 25, 2020
Phase:
Study type: Observational

To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods. To assess the Ease of Use of the Allegro in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package insert sheets, a Quick Reference Guide poster and Instructions for Use. No training, coaching, or prompting will be provided other than clarifying the protocol.