Gestational Diabetes

Researchers are evaluating how well symphysis fundal height (SFH) measurements alone compare to SFH combined with point of care ultrasound (POC-US) measuring fetal abdominal circumference (AC) for detecting small or large for gestational age infants among low-risk pregnant women after 35 weeks' gestation. The study aims to improve prenatal identification of abnormal fetal growth, which is linked to risks for mother and baby. This open-label, randomized trial is investigator-sponsored and focuses on low-risk pregnancies managed by midwives. Participants are randomly assigned to one of two groups: one group will have fetal growth monitored using SFH measurements alone, while the other will have SFH plus POC-US to measure fetal AC and assess amniotic fluid volume. Measurements occur at scheduled antenatal visits at 35-38, 40, 41, and beyond 41 weeks' gestation. If screening suggests abnormal growth or amniotic fluid levels, a formal obstetric ultrasound by a specialist will be performed. All women will have POC-US at 41 and 41+ weeks to check amniotic fluid, regardless of group. During the study, midwives will review medical histories, conduct physical measurements, and perform ultrasound assessments following the assigned method. Researchers will compare prenatal screening results to actual birth weights to identify small or large infants. They will also track the number of formal ultrasounds requested, cases of abnormal amniotic fluid, and maternal and neonatal outcomes. Participation lasts from enrollment at 35-38 weeks through delivery and initial postnatal assessment, about one year on average.

This research aims to compare the effectiveness of monitoring blood sugar levels at 1 hour versus 2 hours after meals in pregnant women diagnosed with Gestational Diabetes Mellitus who require treatment. The study focuses on understanding which monitoring time better supports managing blood sugar during pregnancy to improve outcomes for both mother and baby. Participants are pregnant women attending an antenatal clinic and are treated with metformin, insulin, or a combination. Participants will be randomly assigned to monitor their blood sugar either 1 hour or 2 hours after meals using self-monitoring of capillary blood glucose. Their blood sugar is tracked at seven staggered points to provide a detailed profile. This monitoring continues until delivery, with participants followed regularly in the research clinic. Throughout the study, women will have regular visits to assess their health and that of their baby. Researchers will collect data on mode of delivery, gestational age at birth, and fetal weight. They will also monitor maternal and perinatal complications from randomization to delivery. The total participation lasts from enrollment until the birth of the baby, allowing detailed observation of pregnancy outcomes related to the glucose monitoring method.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups: one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.

Researchers are evaluating TQF3250 capsules, a biased GLP-1 receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., in healthy adult subjects with hyperglycemia. This Phase 1a clinical trial aims to study the safety, tolerability, and pharmacokinetic characteristics of TQF3250 after single administration and escalating doses. The capsule selectively activates certain pathways of the GLP-1 receptor to potentially offer better effects with fewer side effects. Participants will be randomly assigned to receive either a TQF3250 capsule or placebo. The treatment involves oral administration in two cycles of 10 days each. One group will take the capsule while fasting once, and the other group will take it once per cycle after eating to assess the food's influence. The study uses quadruple masking to maintain blinding. During the study, participants will be monitored closely for adverse events, vital signs, electrocardiograms, and laboratory test results up to 20 days. Researchers will assess changes in body temperature, heart rate, respiratory rate, blood pressure, and blood oxygen levels within 24 hours of dosing. Pharmacokinetic measures such as peak drug concentration and drug exposure over time will also be evaluated. Participants are expected to comply with study procedures and dietary requirements throughout the trial.

Researchers are evaluating the effect of Bragg Apple Cider Vinegar (ACV) liquid on blood sugar levels after eating carbohydrates in healthy adults aged 20 to 50 years. The main goal is to see if there is a difference in blood glucose levels measured over 120 minutes after consuming ACV compared to a placebo. This controlled clinical trial uses a randomized, single-blind, cross-over design to study this question. Participants will consume either one tablespoon of Bragg ACV liquid or four ounces of water as a placebo following a standardized carbohydrate load. The trial involves two study arms where participants receive both treatments at different times. Blood samples will be taken to measure glucose, insulin, and other markers over a two-hour period after intake. The study is sponsored by Bragg Live Food Products and is scheduled to run from August 2025 to March 2026. During the study, participants will undergo blood draws at multiple time points up to 120 minutes post-consumption. Researchers will track blood glucose and insulin levels to assess the impact of ACV versus placebo. Participants will be asked to maintain stable lifestyle habits and comply with dietary guidelines before clinic visits. Safety and adherence will be monitored throughout the study, which involves healthy volunteers without serious medical conditions. Total participation time varies based on study visits.

Researchers are studying how metabolism relates to body composition and body surface area (BSA) in a wide range of people, including healthy individuals and those with conditions like diabetes, obesity, kidney disease, or cancer. They aim to find more accurate ways to measure metabolism and understand how measured BSA compares to estimates based on height and weight. This observational natural history study is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Participants will spend 2 days and 1 night in the hospital for testing. They will provide medical history and information about their activity, diet, and lifestyle, and consume a special diet during the stay. Tests include lying under a clear hood to measure breath gases, body scanning while lying down and standing, measuring electrical signals through the body, hand strength tests, and providing blood and urine samples after drinking salty water. Participants may return for up to 8 such visits per year, with at least 2 weeks between visits. During the study, researchers will monitor resting energy expenditure, body composition, and BSA through these tests and questionnaires. They will track differences between measured and predicted BSA and how BSA relates to energy use. Safety and ability to complete tests are monitored, and the total participation time depends on the number of visits. This detailed assessment helps understand metabolism across health and disease states.

Researchers are exploring how giving pregnant individuals a choice among different nutrition and exercise programs affects their ability to stick to the program and maintain healthy pregnancy outcomes. The study focuses on preventing excessive gestational weight gain by comparing adherence to three lifestyle intervention strategies within the Nutrition and Exercise Lifestyle Intervention Program (NELIP). This research uses a pseudo-randomized design to examine if choice improves participation compared to no choice in pregnant individuals between 12 and 18 weeks of pregnancy with a single fetus. Participants are divided into two groups: one group chooses from three intervention strategies and the other group is matched to a choice participant and receives the same strategy without choice. The three strategies vary in timing of introducing nutrition and exercise components; either both simultaneously starting at 12-18 weeks, or nutrition first followed by exercise at 25 weeks, or exercise first followed by nutrition at 25 weeks. The exercise involves a supervised walking program with gradually increasing duration, and nutrition is based on a modified gestational diabetic meal plan tailored per participant. The full program continues until delivery, with final intervention measures between 34 and 36 weeks gestation. Participants will be monitored weekly for adherence using a point system, with additional assessments of satisfaction and health outcomes like weight gain, birth measurements, and pregnancy complications. Follow-up visits occur at birth and at 2, 6, and 12 months postpartum to track maternal and infant health. The study collects detailed data on nutrition, exercise, and pregnancy progress to understand how choice impacts adherence and outcomes over this extended timeline.

Researchers are evaluating the efficacy, safety, and patient-reported outcomes of GZR4 compared to Insulin Icodec in adults with Type 2 Diabetes Mellitus (T2DM) who are already being treated with basal insulin. This Phase IIIb clinical study aims to better understand how these treatments perform, either alone or with other non-insulin antidiabetic agents, in managing blood sugar levels in this population. The study involves two groups: one receiving GZR4 and the other receiving Insulin Icodec. Both treatments are administered subcutaneously once weekly using a treat-to-target dosing approach. Participants will continue their basal insulin treatment during the study period. Participants will be monitored over 26 weeks, with researchers measuring changes in HbA1c levels from baseline to week 26 as the primary outcome. Secondary outcomes include tracking hypoglycemia events, adverse events, and changes in weight. Safety and treatment effects will be assessed through regular visits and evaluations throughout the study period.

Researchers are studying how serum kisspeptin levels change throughout pregnancy in women with polycystic ovary syndrome (PCOS). This study aims to understand the relationship between kisspeptin, insulin, glucose, and testosterone levels, and to explore whether kisspeptin can predict gestational diabetes mellitus (GDM) and other pregnancy complications in PCOS patients. The study is observational and focuses on pregnancies affected by PCOS using the 2003 Rotterdam diagnostic criteria. The study includes two groups: pregnant women aged 18 to 40 diagnosed with PCOS before pregnancy, and healthy pregnant women in the same age range without PCOS. Participants will be registered for prenatal check-ups during the first trimester. This is an observational study, so no specific treatments or interventions will be given. Researchers will monitor kisspeptin and related hormone levels at different stages of pregnancy. Participants will be followed throughout pregnancy, with assessments to measure dynamic changes in serum kisspeptin over 40 weeks. The study will also evaluate how kisspeptin levels relate to the development of GDM and insulin resistance. Participants will undergo regular check-ups, laboratory tests, and hormone measurements. The study will help understand hormonal changes in PCOS pregnancies and their potential impact on complications, with a total participation time covering the full pregnancy period.