Implementation of a Pragmatic Approach to Lower <b>Diabetes</b> Mellitus Risk After a Diagnosis of <b>Gestational</b> <b>Diabetes</b> Mellitus
This study is testing whether daily metformin for 1 year postpartum can reduce risk of diabetes in patients who had gestational diabetes. Typical care for prediabetes after gestational diabetes is counseling on diet and lifestyle. This study is researching whether management of diabetes prevention is more effective with the drug metformin. This study will be conducted at Tufts Medical Center.
NCT05280496 — Diabetes Mellitus, Type 2
Status: Active, not recruiting
http://inclinicaltrials.com/diabetes-mellitus-type-2/NCT05280496/
Effects of Fetal Programming on the Metabolic, Cardiovascular, Neurocognitive and Reproductive Health of Offsprings and Their Mothers After Pregnancies With <b>Diabetes</b>
The primary objectives of the proposed project are to assess the long-term effects of prenatal exposure to gestational diabetes or diabetes on the maturation and health of the offspring. In addition, the long-term changes on the health of the affected mothers will be investigated, taking into account the metabolic adjustment during index pregnancy. The expected results will help to establish possible prevention strategies to fight the epidemic of non-communicable diseases for the offspring and the mothers.
NCT04417452 — Diabetes, Gestational
Status: Active, not recruiting
http://inclinicaltrials.com/diabetes-gestational/NCT04417452/
Active Management of Postpartum <b>Diabetes</b> Screening After <b>Gestational</b> <b>Diabetes</b>: a Randomized Controlled Trial
Assess postpartum diabetes screening in GDM patients with initiation of a reminder system in the postpartum period
NCT02520336 — Diabetes, Gestational
Status: Recruiting
http://inclinicaltrials.com/diabetes-gestational/NCT02520336/
A Prospective Randomized Trial of Home Versus Hospital Care in Glucose Monitoring of <b>Gestational</b> <b>Diabetes</b> and Mild <b>Gestational</b> Hyperglycemia
Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with increased perinatal and maternal complications. The most serious maternal complication is the risk of developing type 2 diabetes after 10-12 years of the delivery. Perinatal complications include fetal macrosomia with consequent increased risk of obstetrical trauma and hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and metabolic disorders at birth. Regardless of the diagnosis of diabetes and mild gestational hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. For the tight control of blood glucose, pregnant women are treated as home care (outpatient) or hospital care. Objective: To evaluate the cost-effectiveness and safety of home versus hospital care of gestational diabetes and mild gestational hyperglycemia.
NCT01441518 — Gestational Diabetes Mellitus
Status: Completed
http://inclinicaltrials.com/gestational-diabetes-mellitus/NCT01441518/
Families Defeating <b>Diabetes</b>: Canadian Intervention for Family-Centered <b>Diabetes</b> Prevention Following <b>Gestational</b> <b>Diabetes</b> (GDM)
No evidence-based, evaluated, population-appropriate resources exist to translate Type 2 diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such large-scale interventions include: - the need to identify, then target specific at-risk populations - significant time-delays before any program effects on T2DM incidence may manifest. However, women with gestational diabetes (GDM) are a readily identifiable study cohort at significant risk for recurrent GDM and T2DM—hence GDM women provide important opportunities for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely targeting women with recent GDM in the context of their families. FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with recent GDM, within their family context. Five Canadian sites and 177 women will participate. Multifaceted information and behavioural change support will be provided for diet, weight loss, and activity through: seminar, walking groups, electronic updates, password-protected social networking site. Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices; HbA1C; body habitus at study onset/during study/12 months/24 months. Consenting immediate family members will have protective knowledge/diet/exercise choices/body habitus measures documented at study onset/12 and 24 months.
NCT01425645 — Diabetes Prevention
Status: Completed
http://inclinicaltrials.com/diabetes-prevention/NCT01425645/
Metformin in <b>Gestational</b> <b>Diabetes</b> and type2 <b>Diabetes</b> in Pregnancy in a Developing Country
The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy metformin treatment compared with insulin will result in better perinatal and maternal outcome and improved treatment acceptability with low or noadditional insulin requirement.
NCT01855763 — Type 2 Diabetes
Status: Active, not recruiting
http://inclinicaltrials.com/type-2-diabetes/NCT01855763/
Is it Possible to Screen for Type 2 <b>Diabetes</b> at Day 2 <b>Gestational</b> <b>Diabetes</b> Mellitus Postpartum?
Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. The objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.
NCT00921882 — Type 2 Diabetes
Status: Completed
http://inclinicaltrials.com/type-2-diabetes/NCT00921882/
Can "Continuous Glucose Monitors" (CGMS) Improve Postpartum (PP) <b>Gestational</b> <b>Diabetes</b> (GDM) Screening for <b>Diabetes</b>?
Among women who experience glucose abnormalities during pregnancy, screening during the postpartum period offers a window of opportunity for early identification of diabetes and prediabetes. The rates of postpartum type 2 diabetes (T2D) screening with an OGTT for women with GDM are not optimal given the majority of women with GDM fail to return for postpartum glucose testing. Continuous glucose monitoring (CGM) systems have been recognized as an ideal method of monitoring glycemic control in diabetic patients. CGM has been used in diabetic patients primarily as a management tool allowing a more acceptable and reliable glucose reading and control than self-monitoring of blood glucose (SMBG). There is a need to improve diabetes testing after childbirth in women who experienced gestational diabetes. This will allow investigators to target their efforts to improve the early diagnosis and treatment of diabetes following GDM. No studies conducted to date have not comprehensively examined whether CGM after delivery can be used in women with a recent history to predict their risk of diabetes. This research study is being done to assess the acceptability, feasibility, and accuracy of using a glucose sensor (also known as a continuous glucose monitor or CGM) after childbirth as a diagnostic test that can help identify women who are at risk of developing diabetes after having gestational diabetes and explore its correlation to the standard postpartum oral glucose tolerance test as well as a HbA1c and fructosamine test.
NCT06057805 — Postpartum Gestational Diabetes Mellitus
Status: Recruiting
http://inclinicaltrials.com/postpartum-gestational-diabetes-mellitus/NCT06057805/
A Feasibility Randomised Controlled Trial of a Mobile Phone Application for the Primary Prevention of Type 2 <b>Diabetes</b> in Malaysian Women With <b>Gestational</b> <b>Diabetes</b> Mellitus.
Gestational diabetes mellitus (GDM) is an increasingly common condition of pregnancy and is associated with adverse foetal, infant, and maternal outcomes. Over 50% of women with history of GDM will develop type 2 diabetes (T2D) in later life. Asian women experience disproportionate risk of both GDM and T2D compared to women from other ethnic groups. Lifestyle interventions have been proven to be effective in preventing progression to T2DM in high-risk populations. This is a two-arm, parallel feasibility RCT. Sixty Malaysian women with GDM will be randomized to receive the intervention or standard care in the antenatal period to 12 months postpartum. The intervention is a diabetes prevention intervention delivered via a smartphone application developed based on the Information-Motivation-Behavioral Skills (IMB) model of behavior change and group support utilizing motivational interviewing, which will provide women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care.
NCT05204706 — Gestational Diabetes
Status: Recruiting
http://inclinicaltrials.com/gestational-diabetes/NCT05204706/
<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: Not yet recruiting
http://inclinicaltrials.com/gestational-diabetes/NCT05112588/