Obesity Clinical Trials

The study is testing the new medicine NNC0662-0419 in people living with overweight or obesity. The purpose of the study is to look into the amount of the new medicine NNC0662-0419 in participants blood after one dose. And also look into how safe and how well the study medicine is tolerated in people living with overweight or obesity. NNC0662-0419 is a new medicine which cannot be prescribed by doctors. NNC0662-0419 is currently being tested in humans and the dose participants will receive has been found safe and tolerable. Participants will get a single dose of NNC0662-0419 given by study staff as a single injection under participants skin. Like all medicines, the study medicine may have side effects. The study will last up to 2 months. Read Less

Background: At least 30% of Americans have fatty liver disease. This means that they store too much fat in the liver. At the moment lifestyle changes are the only way to treat this problem. Objective: To test how (1) a low-carbohydrate diet and (2) a supplement called nicotinamide riboside (NR) affect how a person s body uses dietary fat. Eligibility: Men aged 18 to 65 and women aged 18 to 50 who are healthy volunteers with a body mass index (height to weight ratio) of 25 or more. Adults with maturity-onset diabetes of the young type 2 (MODY2) are also needed. Design: Participants with diabetes will have 1 screening visit and a 9-day clinic stay. Healthy volunteers will have 1 screening visit and 2 clinic stays of 1 to 2 weeks each. During screening, all participants will have a physical exam with blood and urine tests. They will have their heart rhythm measured while riding a gym bike. NR is a pill taken by mouth. Only healthy volunteers will take the NR, for 14 days at a time, during 1 clinic stay. During their other stay, they will take placebos; these are pills that look like the study supplement but contain no NR. During each clinic stay, all participants will eat a normal American diet. Then they will eat a ketogenic "low-carb" diet for 5 days. Participants will have many tests, including: Sleeping every night and having two 24-hour stays in a special room that measures the gases their body uses and produces. Drinking a high-fat shake, then remaining seated for 5 hours while their blood and breath are monitored. Having a substance injected into the arm and remaining seated for 3 hours while their blood is measured. Wearing monitors to measure their activity levels. Another monitor will measure their blood glucose levels. Having imaging scans. ... Read Less

The rate of weight gain in the first year of life is risk factor for future obesity. The study will test (1) a model of l mechanisms underlying the development of emotion, attachment, and nutritive intake; and (2) the association with maternal feeding behavior, child eating behavior, dietary intake, and adiposity. Read Less

Background: Type 2 diabetes is a disease that affects blood sugar levels. Complications can include heart and blood vessel (vascular) diseases. Rates of type 2 diabetes have tripled in children and young adults over the last 40 years. Vascular diseases are also increasing in young people. Objective: To learn more about factors, including type 2 diabetes, that may cause vascular disease in young people. Eligibility: People aged 12 to 25 years who (1) have type 2 diabetes; (2) are overweight but not diabetic; (3) or are lean and healthy. Biological parents are also needed. Design: Young participants will visit the NIH clinic once a year for up to 25 years. Each visit will take 4 days. Before each visit, participants will wear devices to track their sleep, activity, and blood sugar levels for 7 to 10 days. At each visit, participants will have tests including: Samples: They will provide blood, urine, and stool samples. Heart: They will ride a stationary bike for 6 minutes with stickers applied to their chest. Scans: They will lie on a bed that slides into a tube; the machine will take pictures of the inside of their body. Energy: They will wear a hood over their head to measure the air they breathe. Social stress: They will give a speech for 10 minutes to show their body s response to stress. Glucose: They will drink a sweet drink to see how their blood sugar changes. Biological parents will have 1 study visit. They will have blood tests. They will fill in questionnaires about their lifestyle and stress. ... Read Less

This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. Read Less

To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients). Read Less

Background: In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home. Objective: To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks. Eligibility: Adults aged 19 to 50 years with a body mass index of 25 or more. Design: Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples. Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants homes. They will eat only the foods delivered. Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period.... Read Less

Background: Children s weight has increased sharply in recent years. This may put them at higher risk for health problems. High blood glucose in a pregnant mother and too much weight gain during pregnancy also may have long-term effects on the child s health. Children who become overweight or obese during childhood tend to remain so as adults. Researchers want to study many risk factors during and after pregnancy, and how these affect a child s development. They will also follow the mother s health and well-being after pregnancy. Objectives: To learn how a pregnant mother s environment, lifestyle, and health conditions may affect her child s growth and development from birth until adulthood. Eligibility: American Indian/Alaska Native (AI/AN) or Hispanic adult pregnant women and their offspring. Design: Mothers will have 3 visits during pregnancy. In the child s first year, mothers will have 2 visits and their child will have 4. Children will have 2 visits in their second year and 1 each year until they turn 18. Mothers will have a visit 2 years after birth and 4-5 years later. Both the mother and child s medical records will be reviewed. They will have physical exams and give blood and stool samples. Mothers may give cord blood and placenta samples. They will give breastmilk and urine samples. They will fill out questionnaires. They will have an ultrasound. They may get an activity monitor. Mother and child will be followed until the child s 18th birthday. Read Less

African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. To address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for African American adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. The overall goal of the project is to reduce cancer and obesity-related health disparities among African Americans. Read Less

Background: Diet-induced thermogenesis (DIT) is the amount of energy one s body uses to eat food, absorb the nutrients from the food, and process those nutrients. Researchers would like to understand more about how changing the balances of protein, fat, carbohydrates, and total calories in the diet can affect DIT. Objective: To learn how different diets can change a person s DIT. Eligibility: Healthy people aged 18 to 60 years who have not intentionally lost weight in the past 6 months. Design: Participants will stay in a clinic for about 35 days. They will eat only the food provided. They will receive 8 different diets during the study, including 7 test diets. Participants will undergo multiple tests. They will be screened with blood and urine tests and a test of their heart function. During the first few days: Their waist, thigh, and neck circumference will be measured. They will have a DXA scan: They will lie on a padded table for about 20 minutes while an instrument measures the amount of fat in their body. They will be tested for diabetes. They will answer questionnaires about topics including eating behavior, hunger, and stress. Throughout the study: Their weight will be measured daily. Blood tests will be repeated. They will stay in a metabolic chamber a total of 9 times. They will remain in a closed room for 24 hours while researchers monitor the room temperature and levels of oxygen and carbon dioxide. Participants will collect all their urine for each 24-hour period. ... Read Less

Protocol Number: 22DK0002 Title: Effects of Ultra-processed versus Unprocessed Diets on Energy Metabolism Background: Many diets worldwide include both processed and unprocessed foods. Researchers want to study the effects these foods have on a person s health. Objective: To study how different diets affect a person s health and metabolism. Eligibility: Adults aged 18 60 without diabetes who have stable weight and can exercise. Design: Participants will be screened with: Medical history Physical exam Heart tests Resting energy expenditure (to determine calorie needs) Blood and urine tests 20-minute stationary bicycle session Food, diet, and mental health questionnaires Participants will stay at NIH for 4 weeks. They will receive 3 meals a day and may eat as little or as much as they want. The diet will change each week. Their weight will be recorded daily. They will ride a stationary bicycle daily. Each week, they will do the following: Spend 1 day in a special room that assesses their metabolism Have 24-hour urine collections Give skin and fecal samples Repeat some screening tests Have scans to measure body fat Complete computerized behavior tasks Wear an activity monitor to track physical activity Wear a glucose monitor. A sensor will be inserted under the skin with a small needle. It will be replaced weekly. Take taste tests. They will swish water and flavored liquids around in their mouth and pick which ones had a non-neutral taste. They will also compare liquids for which ones taste better. Participation will last for 4 weeks. Sponsoring Institution: National Institute of Diabetes and Digestive and Kidney Diseases ... Read Less

This observational natural history study will follow individuals with MEHMO (Mental disability, Epileptic seizure, Hypopituitarism/Hypogenitalism, Microcephaly, Obesity) syndrome or an eIF2-pathway related disorder, who have symptoms such as intellectual delay, seizures, abnormal hormone and blood sugar levels, and decreased motor skills. No current treatment for these conditions is available. A major impediment to the testing of potential therapeutic interventions is the lack of well-defined outcome measures. This protocol seeks to identify biochemical and clinical markers to monitor disease progression, and better understand the natural history of these conditions. Any person diagnosed with MEHMO syndrome or related conditions, who can travel to the NIH Clinical Center can participate in this study. The study involves: * General health assessment and evaluation * Imaging studies * Laboratory tests * Collection of blood, urine, spinal fluid, skin biopsy. Read Less