<b>Gestational</b> <b>Diabetes</b> - A Randomized, Controlled Trial PrEvention of PostPartum <b>Diabetes</b> Study (the PEPP <b>Diabetes</b> Study)
Gestational diabetes is the most common metabolic abnormality during pregnancy. In a Swedish population 2-10% of all pregnant women are diagnosed with gestational diabetes mellitus (GDM). The frequency differs dependent of methods for screening and diagnostic references, even within Sweden. Women with GDM have about 50% risk to develop manifest type 2 diabetes (T2DM) within 20 years. Most counties in Sweden have a recommendation to follow women with GDM yearly with an examination and an oral glucose tolerance test (OGTT). Unfortunately, this recommendation often fails, partly due to limited resources at the health care units but also due to lack of compliance from the women. Often after the baby is born focus is changed from the mother to the child and only 30.7% of the women with one or more risk factors performed an OGTT, despite stipulated OGTT in local guidelines. The diagnose GDM is under debate and Sweden has started to implement the recommendations from World Health Organisation (WHO) from 2013 with a lower cut-off for GDM, which will increase diagnostic sensitivity and consequently increase the number of women diagnosed with GDM. The plan was to conduct a randomized, clinical trial testing implementation the new recommendations in Sweden step-wise from 2018 and onwards. The recruitment is now complete and the results are expected to be published in 2021. The overarching aim of this study is to conduct a randomized, controlled clinical trial to test the effect of a model for a lifestyle intervention in clinical practice, using technical support as well as personal, individual support. The intervention is based on the existing organisation and structure in Primary Care and would thus be inexpensive and straight-forward to implement. An additive aim is to explore background mechanisms for the development of type 2 diabetes in women with gestational diabetes.
NCT05112588 — Gestational Diabetes
Status: Recruiting
http://inclinicaltrials.com/gestational-diabetes/NCT05112588/
Tight Versus Standard Glycemic Targets for Pregnant Women With <b>Gestational</b> <b>Diabetes</b> and Type 2 <b>Diabetes</b>
The purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association (ADA) and the American College of Obstetricians and Gynecologists (ACOG) would improve overall outcomes in pregnant patients with diabetes. Eligible pregnant women with a diagnosis of gestational diabetes or Type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ADA and ACOG (control arm), or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy (intervention arm). The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. The primary outcome will be a 250-gram difference in birth weight between the two study arms. Secondary maternal and neonatal outcomes of interest will also be compared between the two study arms.
NCT04672031 — Diabetes Mellitus, Type 2
Status: Recruiting
http://inclinicaltrials.com/diabetes-mellitus-type-2/NCT04672031/
Exploring Nutritype Signature of Type 2 <b>Diabetes</b> Risks in Women Post-<b>Gestational</b> <b>Diabetes</b> Mellitus
Women post-gestational diabetes mellitus (GDM) have more than 7-fold increased risk of having future type 2 diabetes mellitus (T2DM). While a healthful dietary pattern reduces the risk of diabetes in post-GDM, no data support a dietary pattern tailored to the Malaysian diet. To address this issue, the investigators propose to determine the effects of dietary patterns and plasma metabolites in predicting the risk of T2DM known as the Nutritype model. The aim of this study is to identify Nutritype signatures of T2DM risk in women post-GDM using metabolomics approach.
NCT04190199 — Type 2 Diabetes
Status: Not yet recruiting
http://inclinicaltrials.com/type-2-diabetes/NCT04190199/
Immediate Postpartum Screening for <b>Diabetes</b> Mellitus in Women With <b>Gestational</b> <b>Diabetes</b>.
Immediate postpartum screening for diabetes mellitus in women with gestational diabetes The objective of this study is to determine if screening for type 2 diabetes can be done 24 hours after delivery, versus 6-12 weeks postpartum, in recently delivered women having been diagnosed with gestational diabetes requiring medication therapy in the antecedent pregnancy.
NCT03946631 — Diabetes Mellitus, Type 2
Status: Terminated
http://inclinicaltrials.com/diabetes-mellitus-type-2/NCT03946631/
Prevenção do <b>Diabetes</b> em Mulheres Com <b>Diabetes</b> Gestacional prévio: Estudo multicêntrico de mudanças Intensivas de Estilo de Vida: LINDA-Brasil
Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program implemented within the first year after a pregnancy complicated by gestational diabetes (GDM), in delaying or preventing the development of type 2 diabetes.
NCT02327286 — Diabetes Mellitus
Status: Completed
http://inclinicaltrials.com/diabetes-mellitus/NCT02327286/
Text-message Reminders to Increase Rates of Postpartum <b>Diabetes</b> Screening in Women With <b>Gestational</b> <b>Diabetes</b>
Purpose: The purpose of this study is to see whether a text-message reminder system will increase the number of women who complete their diabetes screening after delivery. Study Design: Prospective randomized control trial Hypothesis: Gestational diabetics will be significantly more likely to follow up with their postpartum screening for diabetes if they receive text-message reminders to set up their lab appointment compared to those who receive usual care.
NCT02013557 — Diabetes, Gestational
Status: Terminated
http://inclinicaltrials.com/diabetes-gestational/NCT02013557/
Key Determinants of Type 2 <b>Diabetes</b> Prevention Among Women With a History of <b>Gestational</b> <b>Diabetes</b> Mellitus
The overall objective of this research project is to study the impact of preventive practices on the T2D-related risk profile among women with and without prior GDM and their children exposed and unexposed to GDM.
NCT01340924 — Type 2 Diabetes
Status: Active, not recruiting
http://inclinicaltrials.com/type-2-diabetes/NCT01340924/
Type 2 <b>Diabetes</b> Risk in Women With <b>Gestational</b> <b>Diabetes</b>
Ten to 50% of women with gestational diabetes (GDM), or glucose intolerance first recognized during pregnancy, develop diabetes within 5 years after delivery. Although intensive interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is unknown if such strategies would be effective in women with GDM. Women with recent GDM, even though no longer pregnant, face significant barriers to lifestyle modification, including caregiving responsibilities and low perception of risk. Web-based programs can reinforce physical activity through visual feedback of pedometer output, tailored messaging, education, and on-line communities. Such a program is currently available for adults with chronic disease and is led by Dr. Richardson, a co-PI on this application. Using data from focus group and survey work conducted by Dr. Kim, the other co-PI, this program can be modified to women with recent GDM. For Specific Aim 1, we propose to adapt a chronic disease web-based pedometer program to women with recent GDM. For Specific Aim 2, we propose to conduct a pilot and feasibility study of the program. The intervention will last 12 weeks.
NCT00862602 — Gestational Diabetes
Status: Completed
http://inclinicaltrials.com/gestational-diabetes/NCT00862602/
Mailing Recommendations to the Individual or Physician to Increase Screening for Type 2 <b>Diabetes</b> in Women With Previous <b>Gestational</b> <b>Diabetes</b>: Clinical Trial.
In 1998, The Canadian Diabetes Association published guidelines that recommended women diagnosed with gestational diabetes mellitus (GDM,) should be screened postpartum for Type 2 diabetes using a glucose tolerance test. We determined the rate of screening for Type 2 diabetes at the Ottawa Hospital before and after the publication of this guideline and found that none of the women in either period had been screened following this recommendation. We believe a reminder letter outlining the recommended screening test sent to the patient and/or her family physician would increase screening for Type 2 diabetes in women with previous GDM.
NCT00212914 — Gestational Diabetes
Status: Completed
http://inclinicaltrials.com/gestational-diabetes/NCT00212914/
Mobile Health App to Reduce <b>Diabetes</b> in Latina Women With Prior <b>Gestational</b> <b>Diabetes</b>
The investigators will conduct a pre-post study to evaluate the effectiveness of the Hola Bebe intervention on improving self-efficacy for healthy eating and physical activity, and on weight loss among Hispanic women with recent GDM. The Hola Bebe app provides a unique opportunity to provide an effective, culturally tailored lifestyle modification program. The investigators will provide training to health educators at the two participating sites to ensure consistency and fidelity of implementation.
NCT05489172 — Gestational Diabetes Mellitus
Status: Completed
http://inclinicaltrials.com/gestational-diabetes-mellitus/NCT05489172/