Active clinical trials for "Diabetes, Gestational"

Background: Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention. Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India. Study design: Cluster randomised pilot study of 4 primary care centres (PHCs) in two diverse areas of rural India. Outcome: The primary objective of this pilot study is to address the feasibility of the SMARThealth Pregnancy intervention.

Investigators have taken the learning from various programs to develop a new lifestyle program (LIVING) that has a high probability of being feasible, acceptable and cost-effective in the South Asian context for women with prior Gestational Diabetes Mellitus (GDM). Investigators will optimize this intervention using an iterative, systems-based and user-centered approach. The intervention will be delivered by auxiliary nurse midwives or their equivalent in each participating hospital, representing a strategy of within-system task-shifting to augment scalability and sustainability. Investigators will then evaluate this in a Randomised Controlled Trial (RCT) to determine whether it will reduce the incidence of Type 2 Diabetes Mellitus (T2DM), in a manner that is affordable, acceptable and scalable. This project focuses on generating new knowledge around implementation of a preventive strategy embedded within existing health systems, using mixed-methods evaluation to inform on cost-effectiveness, acceptability and scalability. It represents a case study into "Integrated Innovation TM" incorporating a science component (a program based on behavior change theory that supports a multi-level approach to prevention by combining individually targeted strategies with social support), a social component (an innovative workforce strategy) and a sustainability component (a systems perspective for integration with existing health system infrastructure).

This study evaluates the role of exercise intervention in reducing the risk of gestational diabetes mellitus(GDM) risk of overweight/obese(prepregnancy BMI≥24kg/m^2） Chinese pregnant women. Half of participants will have exercise intervention, while the other half will not. Both of the two group will have regular prenatal care.

The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.

OVERALL OBJECTIVES: To assess the efficacy of a diet and exercise intervention before and/or during pregnancy in the prevention of GDM and its fetal complications in women with high diabetes risk. To assess the cost-effectiveness of a diet and exercise intervention in the prevention of GDM from a socio-economic point of view. To find out whether the intervention can be used to reduce health care costs due to GDM and T2DM. To determine the long-term effectiveness of the above-mentioned lifestyle intervention in the reduction of T2DM incidence among women with prior GDM and their offspring STUDY SUBJECTS Group 1: Women planning pregnancy with a history of diet/insulin-treated GDM or BMI >30 kg/m2. N= 250 + 250. Group 2: Women in early pregnancy with a history of diet/insulin-treated GDM or BMI >30 kg/m2. N= 250 + 250 METHOD The Finnish multi-center randomized controlled intervention trial started in the maternity hospitals of Helsinki and Uusimaa District Area 1/2008 and in the South-Karelia Central Hospital in Lappeenranta in 9/2008. 1000 women at high GDM risk will be recruited. Half of the subjects are randomized into the intervention group and the other half act as controls receiving only standard antenatal care in addition to the laboratory tests taken and questionnaires administered by the RADIEL study. The active intervention arm of the study will be carried out in a structured, standardized manner by diabetes nurses and nutritionists specifically trained for their tasks. The intervention includes: Structured visits to diabetes nurse every 3 months before and during pregnancy as well as at 6 weeks, 6 and 12 months post partum. Visits include e.g. structured counseling on diet and exercise, setting of specific goals, follow-up of achievements, laboratory tests and measurements Structured group visits to nutritionist at the moment of enrollment in the study, at the beginning of pregnancy as well as at 6 and 12 months post partum. Additional individual visits are booked if needed. Services of physical activity advisors are provided by the study subjects' cities of residence free of charge to all who wish to receive extra counseling on exercise. If exercise goals are not met, study subjects book an appointment with the physical activity advisor. LIFESTYLE TARGETS: 1.Weight: A weight loss of 5-10% before pregnancy if BMI > 25 and/or limited weight gain during the first two trimesters in pregnancy if BMI > 30. 2.Exercise: A minimum of 30 min. of exercise 5 times per week or 50 min. 3 times per week of moderate intensity exercise (Borg 11-15). Daily household and/or transportation physical activity. 3.Diet: Increased intake of vegetables, legumes, fruits and berries, whole grain and fiber, low-fat dairy, vegetable fats; and use of "plate model". Total energy intake: 1600-1800 kcal/day, with 40-50 E% carbohydrates, 30-40 E% fats, 20-25 E% protein. MEASUREMENTS of maternal variables: AT THE MOMENT OF ENROLMENT TO THE STUDY, and every 3 months before pregnancy: (1) Waist circumference, blood pressure, pulse, weight, height (2) i.e. 2-hour OGTT, fP-insulin, fP-glucose, , GHbA1c, lipids, P-hCRP, P-IL-6, S-A1Glypr, leptin. (3) Background questionnaire (4) 15-D-questionnaire: health-related quality of life. (7) Food diary (2+1). Exercise diaries daily for one week. PREGNANCY At the end of each trimester: (1) The same tests and measurements as in pre-pregnancy period. 2h-OGTT at H10-14 and at H24-28. (2) Questionnaire, 15-D questionnaire, EDPS (=Edinburgh post-partum depression scale) questionnaire for screening mood disorders at H10-13. (4) Food diaries (2+1), and exercise diaries daily for one week at H10-13 and H34-36. POST PARTUM PERIOD (Groups 1-2) At 6 weeks, 6 and 12 months post partum: (1) The same follow-up tests and measurements as at the beginning. Lipids checked only at 12 months post partum. (2) 2-hour OGTT 6 weeks and 12 months post partum (3) Questionnaires at all visits. (5) Food and exercise diaries at 12 months post partum. MEASUREMENTS of child's variables at birth (1) weight (2) height (3) head circumference (4) From delivery records: Mode of delivery, Apgar scores, any perinatal complications, operations, need of neonatal intensive care and length of hospital. (3) Laboratory tests from cord blood. TIMETABLE Recruitment started in February 2008 and ended in autumn 2011 when about 800 subjects had been recruited to the study. Intervention will continue until 2014 (including pre- and postpartum periods). Long-term follow up of both mothers' and children's cohorts starts in 2014 and has been planned to continue up to 10 years postpartum. Data analysis starts in autumn of 2013 and results will be reported from 2014 onwards in international peer-reviewed journals.

Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a condition that can adversely affect the pregnant woman, her developing fetus and future events for both. To reduce GDM risk, we will develop and implement an in-person team and web-based nutrition and exercise program for women, beginning in their first trimester. A scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams (5 women/team), will be developed and implemented among pregnant employees and/or their spouses. Each weekly thirty minute session will focus on achieving 30-minutes of moderate daily physical activity with nutrition targets of five servings of fruits and vegetables, 3 servings of whole grains and lower fat food choices. Diet, exercise and lab assessments will occur before enrollment during the first trimester, each subsequent trimester and 12 weeks after delivery. In addition to exercise and diet survey results, we will assess fasting glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood pressure, lipid and lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12 weeks post delivery, as well as gestational birth age, Apgar score, delivery mode and infant birth weight, and weekly health thermometer self-ratings during the assessment period.

Currently, about one third of all women entering pregnancy are obese. The prevalence of metabolic disorders during pregnancy has increased concurrently with the rise in maternal obesity. Although dietary interventions are used routinely to reduce metabolic disease in non-pregnant obese individuals, no specific dietary advice is provided to obese, pregnant women unless they develop gestational diabetes mellitus. In this study, the investigators will specifically assess the effect of replacing dairy fats with almonds in a breakfast meal on the postprandial metabolic response. This cross-over, randomized control trial will examine the postprandial metabolic response to 0 or 2 oz of almonds in standardized test meals in pregnant Hispanic women with prepregnancy BMI between 25 and 40. Hispanics are at higher risk for gestational diabetes and the metabolic syndrome. The investigators hypothesize that consuming almonds in place of dairy fat reduces the glycemic response and improves the postprandial lipid profile in these high-risk women.

The purpose of the study is to investigate if the probiotics Vivomixx® can affect gestational weight gain, microbiota and pregnancy complications in pregnant obese women and birth weight body composition of their infants.

The purpose of this study is to assess the feasibility of randomizing pregnant women at high risk for gestational diabetes to a 24-week period of soy food consumption. This study will also examine the effects of soy protein and isoflavones on glucose metabolism and lipid levels among pregnant women at high risk for gestational diabetes, and on child's weight and height at birth and 6 weeks of life.

A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future health of the mother. GDM is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes (DM2) at rates much greater than control groups who did not have glucose intolerance during pregnancy. Liraglutide may potentially delay disease progression in GDM considering the beta -(ß-)cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if the addition of liraglutide to metformin therapy is more effective than metformin alone in improving insulin sensitivity and normalizing insulin secretion in at-risk overweight/obese women with prior GDM.