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2,481 active trials for Diabetes

Caregiving Networks Across Disease Context and the Life Course

Background: In the U.S., about 53 million informal, unpaid caregivers provide care to a person who is ill, is disabled, or has age-related loss of function. These caregivers may be adult children, spouses, parents, or others. The stress of providing long-term care affects caregivers health and well-being. Researchers want to learn more about this stress and its effects. Objective: To learn how the caregiving process affects the health and well-being of caregivers over time. Eligibility: Adults aged 18 years and older who are caregivers for a person with a chronic medical condition and who have already given consent to take part in other study activities. Design: Participants will be put in different groups. They will complete some or all of the following tasks over 1 year. They may repeat these tasks once a year for up to 5 years. Participants will fill out 2 online surveys. One will ask about their health and their caregiving experience. The other will ask them to list people in their social network and their care recipient s social network who give them support. Participants will have a 2-part phone interview. It will be audio recorded. In part 1, they will be asked about the people they listed in the survey. In part 2, they will be asked about their caregiving experience and events in the care recipient s life. Participants may fill out a weeklong diary every 3 months. It will ask about their daily social activities, well-being, and stress levels. It will also ask about their thoughts and feelings about caregiving. Participants may give a blood sample each year they are in the study. ...

Bethesda, MarylandStart: September 2021
Gut Microbiota in Metabolic Surgery

Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month and 1-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and the associations of microbiome and metabolites with CVD risk score and improvements in hypertension, diabetes, and dyslipidemia after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.

Nashville, TennesseeStart: August 2021
An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic kidney disease (DKD). FIGARO-BM is an add-on study in which blood draws that were collected in the FIGARO-DKD study are further analyzed. No additional blood draws (also referred to as biological samples) or data will be obtained from the participants, nor will any additional or new study intervention be introduced. No visit or patient contact other than for obtaining the agreement by the patients (also called informed consent) will be required. Inflammation and scarring are both seen as responsible for worsening of chronic kidney disease. There is much information from animal studies that the study treatment finerenone (BAY94-8862) works against inflammation and against scarring (also called fibrosis) in organs such as the kidney. In this exploratory study researchers want to learn more about the study treatment finerenone (BAY94-8862). To find this out, this study will examine substances called biomarkers in blood draws from participants in the FIGARO-DKD study. Biomarkers are used as indicators of biological processes, disease processes or responses to medication. The biomarkers that will be examined stand for inflammation, organ scarring (also called fibrosis), blood vessel function and congestion. The main question of this study is whether there are differences between these biomarkers in the group of participants who received finerenone and the group of participants who received a placebo in the FIGARO-DKD study. A placebo looks like a treatment but does not have any medicine in it. To answer this question, the researchers will compare the levels of these biomarkers between the two groups at different time points after starting the study treatment. Blood samples for this study will be obtained from FIGARO-DKD study sites with a high number of participants who had been treated with finerenone or placebo for at least 24 months. This information will be combined with other information from biomarker examinations already available in the FIGARO-DKD study.

Reservoir, VictoriaStart: August 2021
The Influence of Malnutrition, Diabetes Mellitus, and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population

About 2 billion people worldwide are infected with tuberculosis (TB). Ninety percent of those people have latent TB infection (LTBI). Risk factors like malnutrition, diabetes mellitus (DM), and helminth infection can affect the development of active TB. Researchers want to study LTBI individuals with these issues to see how they may contribute to a person s higher risk for developing active TB. This study will take place in Chennai, India. Objective: To estimate the prevalence of malnutrition, DM, and helminth infections in people with LTBI. Eligibility: People age 14 65 with or without LTBI. Design: Participants will be screened with a medical history and physical exam focused on symptoms of active TB. Those who have TB symptoms will not take part in the study. Those who do not have TB symptoms will have a physical exam with vital signs, height, and weight. They will give blood and stool samples. Participants will be assigned to 1 of 6 groups. They will repeat some of the screening tests. They will give urine samples. Some groups will have a chest X-ray. Some groups will have an ultrasound of the abdomen. Participants will complete a survey about their history of smoking and drug and alcohol use. Participants will have data collected about their nutritional status and body composition. Their skinfold thickness, ratio of waist/hip circumference, and grip strength will be measured. Participants with DM, malnutrition, or helminth infection will be given standard of care or referred for follow-up treatment. Participation will last up to 6 months. ...

ChennaiStart: September 2021
A Study to Learn How Well a Blood Sugar Monitoring System Called Cascade Which Measures Glucose on an Ongoing Basis Works and How Safe it is in Chinese Patients in Usual Practice

Researchers are looking for a better way to help Chinese people who have diabetes to monitor their blood sugar situation. There are 2 types of diabetes. In people with type 1 diabetes, the body's immune system attacks and destroys cells in the pancreas that produce a hormone called insulin. In people with type 2 diabetes, the body does not make enough insulin or does not use insulin well. This results in high blood sugar (glucose) levels. Over time, high blood sugar levels can cause damage to certain parts of the body. These include the eyes, the kidneys, the nerves, and the heart. There are tests and devices available for doctors and patients to measure blood sugar levels. In order to see if the diabetes treatment is workable to stabilize the blood sugar level, repeated blood sugar measurement is always needed. Such tracking of the blood sugar is also called blood sugar monitoring. Blood sugar monitoring tests and devices can however be difficult to use and one test or device may not work for all patients. Researchers think that better monitoring systems would help patients improve the control of their blood sugar levels. This could help to stabilize their blood sugar condition. In this study, the researchers want to learn more about how well a new monitoring system called Cascade works in Chinese patients with diabetes. Cascade is a continuous glucose monitoring system. It regularly measures the level of glucose in the tissue throughout the day and night. Cascade is made up of a small sensor that patients apply in the belly region where it is placed just under the skin, into the so-called subcutaneous tissue. The sensor measures the level of glucose in the fluid that surrounds cells in the subcutaneous tissue. It also has a transmitter which attaches to the sensor and sends the results via Bluetooth to a smart device, which can instantly display the glucose level. The glucose level can then be used to adjust the treatment. The main purpose of this study is to learn how well Cascade monitors glucose levels in Chinese patients when used in usual practice. To answer this question, the researchers will compare the glucose levels collected with the Cascade monitor to the blood sugar levels collected with venous blood glucose testing. This is where a blood sample is taken from the veins, and then the level of sugar in the blood sample is measured. The study will include adult Chinese patients who have type 1 or type 2 diabetes and who the study doctors think need to monitor their diabetes using Cascade and venous blood glucose testing. There will be no study treatments given as part of this study. The patients will be in the study for up to 18 days. The device will be worn up to a maximum of 14 days. The total duration of the study will be about 4 months. The patients will get training on how to use the Cascade monitor and will attach it to their belly area on Day 1 of the study. The patients will wear Cascade for up to 14 days. The researchers will then collect the information about their glucose levels. The study doctors will also take blood samples and measure blood sugar levels using venous blood glucose testing. They will compare the sugar levels recorded from the blood samples to the glucose levels recorded by Cascade at the closest time points. After wearing Cascade for 14 days, the study doctors will remove it from the patients' bellies. About 3 days later, the researchers will call the patients to check for any discomfort that has happened after the removal of the Cascade device. The patients may also take photos of the area and send these to the study doctors. During the study, the study staff will: take blood samples as part of the usual care compare glucose levels recorded by Cascade to the levels recorded from the venous blood glucose tests check the skin for any swelling or areas of rash where Cascade was worn • record any instances of Cascade errors or malfunctioning record any alarms for when glucose levels are too high or too low check the patients' overall health ask the patients about how they are feeling and what medical problems they are having.

Multiple Locations, Many LocationsStart: October 2021
Prevention of Type 2 Diabetes and Gestational Diabetes Among Women in Kisantu, Democratic Republic of Congo

This study aims to develop and implement a long-term program focused on the prevention of type 2 diabetes Mellitus (T2DM) and gestational diabetes mellitus (GDM) in women of reproductive age through lifestyle modification. This is a cluster-randomized trial whereby 6 health centers across Kisantu, Democratic Republic of Congo (DRC) will be randomized to an intervention group (3 health centers) or a comparison group (3 health centers). The intervention group will be provided with a preventive program based on educational + motivational strategies when the comparison group will be limited to an educational strategy only. This study will last 24 months and is limited to women of reproductive age (18-49 years), pregnant and non-pregnant. Evaluation of this research will use mixed longitudinal analyses for healthy lifestyle adherence, anthropometric and clinical indicators, diet quality, and physical activity. Expected results of this study for women of reproductive age include the prevention of T2DM and GDM through the acquisition of healthy lifestyle behavior, reaching and maintaining an optimal weight, blood pressure and glycemia, and adhere to the weight gain recommendations during pregnancy. Other expected achievements encompass improvements in the usability of data capturing systems, expand knowledge among health care providers on effective strategies for T2DM and GDM prevention and improve the technique and precision of measurements concerning health visits among health care providers, among others.

Kisantu, Congo CentralStart: August 2021