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Obesity clinical trials

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NCT ID: NCT06468748 Not yet recruiting - Obesity Clinical Trials

The Effects of Semaglutide on Body Composition and Performance in Military Personnel

Start date: June 2024
Phase: Phase 4
Study type: Interventional

The obesity epidemic presents a growing concern in the United States, affecting more than 42% of adults. This epidemic extends its impact to chronic diseases and escalating healthcare expenses. Its reach has even influenced the military, with more than 20% of Soldiers being classified as obese, based on Body Mass Index ≥30 kg/m2. Current preventative and countermeasures have produced limited success, prompting consideration of pharmacotherapy. Within this context, glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide, have emerged as a promising treatment for obesity. Semaglutide can induce significant weight loss, primarily through fat reduction. However, questions persist regarding its effects on lean mass, physical performance, bone structure, and how it influences the underlying metabolic and hormonal milieu. Furthermore, no studies have been completed in military personnel, who must exercise regularly. Therefore, the investigators will conduct a single-center, open-label, observational trial. The trial will consist of a 24-week semaglutide treatment period and a non-treated 52-week follow-up period. We will test the feasibility and potential benefits of semaglutide in military populations, with a focus on understanding how semaglutide influences body composition, physical performance, hormones, and metabolism. This research holds military significance as obesity rates among service members continue to rise, undermining their medical readiness. Ultimately, it is important to understand if GLP-1RAs can provide a viable solution to obesity in military personnel and if there might be an unexpected effect on physical readiness due to the nature of the weight loss. This could cut down on healthcare expenses by reducing the reliance on weight-related initiatives and, consequently, lowering military separations.

NCT ID: NCT06467955 Recruiting - Obesity Clinical Trials

MagDI Canada Study

Start date: May 10, 2024
Phase: N/A
Study type: Interventional

The objective of the MagDI Canada study is to evaluate the performance and safety of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion as one example of a small bowel clinical procedure requiring a side-to-side anastomosis. The secondary objective includes initial efficacy of the duodeno-ileal diversion using the MagDI System.

NCT ID: NCT06467604 Recruiting - Obesity Clinical Trials

CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users

Start date: June 12, 2024
Phase:
Study type: Observational

This study aims to assess the impact of GLP-1 receptor agonists, semaglutide and tirzepatide, on food cravings and diet quality in individuals with overweight or obesity. Over 24 weeks, up to 150 adult participants will be monitored using questionnaires and dietary records at 0, 12, and 24 weeks to measure changes in diet quality, disordered eating, food cravings, and hunger. This research, conducted with Seen Medical Group at Knownwell Health Clinic, seeks to fill the gap in literature on the dietary quality effects of GLP-1RAs.

NCT ID: NCT06467578 Recruiting - Obesity Clinical Trials

RMR Monitoring Feasibility and Acceptability

Start date: April 19, 2024
Phase: N/A
Study type: Interventional

Obesity is a leading risk factor for chronic diseases such as type 2 diabetes, cancer, and cardiovascular disease. Generic weight management programs that target dietary intake and physical activity have been shown to be ineffective in maintaining weight loss beyond a 6-month period. Personalizing weight management programs produces more weight loss than generic programs, possibly through improved self-efficacy (confidence in one's ability to control weight through behavior). One way to personalize diet goals for individuals is by resting metabolic rate (RMR; 'metabolism'). This study will explore adherence and satisfaction of 6-weeks repeated at-home measures of metabolism using a portable device in healthy adults with and without obesity. Relationships among adherence and satisfaction outcomes to health behavior variables will be explored using dietary recalls, exercise monitors and questionnaires. Investigators will conduct a 6-week, one-arm feasibility study in order to address these questions. Twenty men and women ages 19-65 will be recruited (up to n=25 participants), among which 10 participants will have a body mass index (BMI) of ≥30kg/m2 (classified as having obesity), and the remaining 10 participants will have a body mass index (BMI) of < 29.9kg/m2 (classified as not having obesity). The baseline study visit will evaluate participant's anthropometric measures, RMR using the ParvoMedics TrueOne 2400 and Breezing indirect calorimeters, psychological and behavioural related parameters. An activPAL device will be provided to measure participant physical activity. Completion of a 3-day diet record following the baseline study visit, in which participants keep a record of all food and beverages consumed over 2 weekdays and 1 weekend, is required. Participants will be asked to use the Breezing device from home to measure their RMR one time/week on the same day of the week (± one day) and at the same time each morning for six consecutive weeks following the baseline visit. A weekly Qualtrics survey will be sent to participants to monitor adherence. A follow-up visit after the six weeks will assess participant's body composition using a Dual X-ray Absorptiometry (DEXA), in addition to completion of a user satisfaction interview with a study team member for descriptive analysis. The measures taken at the baseline study visit will be repeated at the follow-up visit.

NCT ID: NCT06466161 Not yet recruiting - Obesity Clinical Trials

Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO)consensus for validation of non-invasive blood pressure (NIBP) devices during pregnancy. Given the known inaccuracies of upper arm cylindrical cuff measurements in morbidly obese patients, a conical cuff which provides more accurate measurements will translate into direct patient benefit via more informed diagnosis and management. Fewer women may be exposed to unnecessary treatment, preterm delivery, and/or cesarean section. Recognizing the increasing prevalence of morbid obesity and hypertensive disease amongst pregnant women in the United States, the identification of a more accurate non-invasive cuff is desperately needed. Increasing the accuracy of NIBP measurements on Labor and Delivery has the potential to directly impact the management of tens of thousands of morbidly obese pregnant women diagnosed with hypertensive disease in the United States every year. Establishing the level of agreement between conical forearm and cylindrical upper arm cuffs will shed light on the presence and magnitude of any disparity between measurement methods. STUDY ENDPOINTS: Primary Outcome Measures: - Agreement between conical and cylindrical cuff systolic blood pressure across groups - Agreement between conical and cylindrical cuff diastolic blood pressure across groups Secondary Outcome Measures: • Agreement between conical and cylindrical cuff mean arterial pressure

NCT ID: NCT06464497 Not yet recruiting - Obesity, Childhood Clinical Trials

Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

This study will address the following aims: Aim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity. Aim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention. Hypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group. Aim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention. Hypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and/or waist circumference at the 8-week follow-up than those in the control group. Secondary Aims: Aim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period. Hypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group. Aim 3: Conduct post-intervention family focus groups to identify how individual/family needs and preferences and social determinants of health (SDOH) may be perceived barriers and/or facilitators of diet adherence to a whole foods diet pattern.

NCT ID: NCT06463223 Not yet recruiting - Metabolic Disease Clinical Trials

HIBOC = Hepatic Imaging Biomarkers in Obese Children

Start date: October 2024
Phase:
Study type: Observational

The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measure, and treatment effects over time.

NCT ID: NCT06461806 Active, not recruiting - Obesity Clinical Trials

Effect of Protein Source During Ketogenic Weight Loss Intervention

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This randomized, controlled, single-blinded study will investigate how the protein source in a high-protein ketogenic diet affects metabolic weight loss outcomes after a 12-week dietary intervention

NCT ID: NCT06461273 Not yet recruiting - Obesity Clinical Trials

Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic (CKM) Syndrome

FiLMED
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The investigators are piloting a 3 month community-based lifestyle medicine program that incorporates experiences and education in urban agriculture, nutrition, culinary arts, and physical fitness to test the hypothesis whether this improves clinical and socio-behavioral outcomes of participants with Cardiovascular Kidney Metabolic (CKM) syndrome (high blood pressure, diabetes, high cholesterol, heart disease, and obesity) in comparison to the current medical care model (usual care) or providing healthy produce (medically tailored groceries).

NCT ID: NCT06461039 Recruiting - Obesity Clinical Trials

A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant

Start date: June 14, 2024
Phase: Phase 1
Study type: Interventional

This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.