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Prediabetic State clinical trials

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NCT ID: NCT05050266 Recruiting - Obesity Clinical Trials

Enhancing Mental and Physical Health of Women Veterans

EMPOWER
Start date: October 21, 2021
Phase: N/A
Study type: Interventional

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in up to 20 VA facilities from 4 regions.

NCT ID: NCT05041491 Recruiting - Pre-diabetes Clinical Trials

Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes

BURST2D
Start date: November 30, 2021
Phase: Early Phase 1
Study type: Interventional

Newly released guidelines recommend increased physical activity (PA) and reduced sedentary behaviors (SB) to improve glycemia and prevent the onset and progression of type 2 diabetes (T2D). Typically, 30-60 min bouts of PA are advocated per day. Although this approach increases PA, it does not decrease the length of the sedentary periods through the day. This is important because recent epidemiological data suggest that frequently interrupting sedentary time improves glucose control even in people who achieve the recommended levels of PA. Preliminary experimental data suggest that breaking up prolonged sedentary time by performing multiple short bouts (5 min) of PA throughout the day, may improve glycemia more than performing a single continuous bout of PA, and thereby potentially be a novel strategy to prevent T2D. The improvement in glycemia was observed even when the total amount of PA and total energy expenditure were matched, suggesting that how and when PA is performed over the day may matter more than how much PA is done. However, important gaps in knowledge remain including: (1) whether similar benefits on glucose control would be observed in adults with prediabetes, a clinically relevant population that is at high risk of developing T2D; (2) whether these effects are sustained or diluted over time, and (3) what are the mechanistic underpinnings. To address these gaps, the investigators propose to measure the acute and chronic effects of PA breaks on glucose control and the underlying mechanisms in individuals at risk of developing T2D. Sedentary men and women with prediabetes (n=66, 50% F) will be randomized to either an intervention designed to interrupt SB with 5-min bouts of brisk walking performed hourly for 9 hours/day, 5 days/week (BREAK) or a control condition consisting of 45-min of brisk walking performed as a single daily continuous bout, 5 days/week (ONE). The two 3-months interventions will be matched for total active time.

NCT ID: NCT05040971 Completed - Obesity Clinical Trials

Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

STEP 10
Start date: September 6, 2021
Phase: Phase 3
Study type: Interventional

This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes. This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar. Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication. Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT05038137 Completed - Breast Cancer Clinical Trials

Time Restricted Eating on Cancer Risk

TREC
Start date: May 4, 2022
Phase: N/A
Study type: Interventional

Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist or dietician to assist with the eating schedule. The study will take last 3 1/2 months.

NCT ID: NCT05035966 Completed - PreDiabetes Clinical Trials

Association of β-amyloid 40 and 42 With Prediabetes

Start date: January 1, 2012
Phase:
Study type: Observational

Background: Previous epidemiological and animal studies have suggested a strong relationship between prediabetes and Alzheimer's disease. Recently, we demonstrated that plasma β-amyloid (Aβ), a potential biomarker for Alzheimer's disease, was elevated in individuals with type 2 diabetes. However, few studies have investigated the associations of plasma Aβ40 and Aβ42 concentrations with prediabetes. Objective: we aimed to investigate the associations of plasma Aβ40 and Aβ42 concentrations with risk of prediabetes in two independent studies. Design: We performed a case-control study and a nested case-control study within a prospective cohort study. In the case-control study, we included 571 newly diagnosed individuals with prediabetes and 571 control participants. Prediabetes individuals were consecutively recruited from subjects who attended the outpatient clinics of Department of Endocrinology at Tongji Medical College Hospital from 2012 to 2015. Concomitantly, we recruited healthy controls from a general population undergoing a routine health checkup in the same hospital. One healthy control was selected at random for each prediabetes individuals according to age (±3 years) and sex. The inclusion criteria of participants were as follows: age ≥30 and ≤80 years, BMI <40 kg/m2, no history of prediabetes and diabetes mellitus, no history of receiving pharmacological treatment for hyperlipidemia, nor any clinically systemic disease, any acute illness, and chronic inflammatory or any infective disease. An independent nested case-control study was conducted within an ongoing cohort study, namely the Tongji-Ezhou cohort. Briefly, 5533 participants, including 3101 retired employees and 2432 working employees, were enrolled from Echeng Stell and received healthcare for a baseline investigation between 2013 and 2015. The first follow-up for all participants was finished by mid-2020. Considering the low incidence of prediabetes among young working employees, we performed the nested case-control study among retired employees. During the follow-up, 119 new-onset prediabetes cases were diagnosed within the retired employees according to fasting plasma glucose. We randomly selected the control participants who matched 2:1 to the cases by age (±3 years) and sex from the retired employees with normal fasting plasma glucose. The inclusion criteria were the same as the case-control study; 2 new-onset prediabetes cases aged >80 years were excluded. Additionally, 17 cases without enough plasma were excluded. Finally, 100 individuals with new-onset prediabetes and 200 well-matched control participants were included for the analysis of the nested case-control study. These two studies were approved by the Ethics and Human Subject Committee of Tongji Medical College. All enrolled participants in the two studies were of Chinese Han ethnicity and provided informed written consent. Plasma Aβ40 and Aβ42 concentrations were simultaneously measured by validated assay platforms from Meso Scale Discovery (MSD; Rockville, MD, USA).

NCT ID: NCT05023993 Active, not recruiting - Prediabetes Clinical Trials

The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer

Start date: June 23, 2022
Phase: N/A
Study type: Interventional

This trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). Nicotinamide riboside is a dietary supplement which is similar to vitamin B3. Information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.

NCT ID: NCT05008276 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)

Start date: September 27, 2021
Phase:
Study type: Observational

Early diabetic kidney disease (DKD) occurs in 50-70% of youth with type 2 diabetes (T2D) and confers high lifetime risk of dialysis and premature death. Youth-onset T2D typically manifests during or shortly after puberty in adolescents with obesity. Epidemiological data implicate puberty as an accelerator of kidney disease in youth with obesity and diabetes and the investigators posit that the link between puberty and T2D-onset may explain the high burden of DKD in youth-onset T2D. A better understanding of the impact of puberty on kidney health is needed to promote preservation of native kidney function, especially in youth with T2D.

NCT ID: NCT04991142 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Models of Nutrition From Continuous Glucose Monitors

Start date: September 17, 2021
Phase:
Study type: Observational

With this study, researchers want to conduct ambulatory studies in which people (healthy, with T2D, or at-risk of T2D) will consume a variety of pre-set and conventional meals in free-living conditions while wearing one or more continuous glucose monitors (CGMs) and, to assess physical activity, a smart watch. With data from these devices, researchers will develop algorithms that can predict the content of a meal.

NCT ID: NCT04984421 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

IMplementation of the Family Support PRogramme A Healthy School Start to Prevent OVErweight and Obesity (IMPROVE)

IMPROVE
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

IMPROVE is an implementation study aiming to explore the effects of two bundled implementation strategies on the intervention fidelity of the Healthy School Start program (primary outcome) while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). Thirty schools in two municipalities will receive the HSS program reaching about 1400 families per school year, for two years.

NCT ID: NCT04979559 Recruiting - PreDiabetes Clinical Trials

Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting

Start date: May 25, 2021
Phase: N/A
Study type: Interventional

Background: Preventing type-2 diabetes mellitus begins with early screening and intervention of prediabetic participants. Until now, prediabetes screening and early intervention have not been optimal. The rapid advancement of technology, as well as its increased use, may provide an opportunity to improve the quality and cost of healthcare services. It is quite practicable to investigate and implement a valid, practical and easy-to-use mobile health application for participants and health staffs in screening and early intervention of prediabetes participants at primary health cares setting. This protocol aimed to identify and develop a valid, practical, and easy-to-use mobile health application for screening and early intervention of prediabetes participants at primary health cares. Methods: This protocol was prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This is a mixed-methods study with sequential exploratory approach. This project will begin with in-depth interview to gather qualitative information regarding mobile health application necessity for prediabetes participants at the primary health cares. The impact of the usage will be studied quantitatively using randomized controlled trial. Prediabetic participants and primary health cares staffs at Yogyakarta province will be the research subjects. The collected findings will be examined based on the type of the data. Discussion: The proposed research aimed to obtain information and trial results regarding mobile health application usage for prediabetes participants screening and early intervention at primary health cares setting.