Clinical Research Directory

Effect of Intensive Nutrition Training, Education, and Support in Gestational Diabetes - The INTENSE-GDM TRIAL

The treatment of gestational diabetes (GDM) primarily revolves around consuming an optimal diet that does not cause blood glucose levels to become excessively high and provides an adequate supply of micro- and macronutrients without resulting in excessive weight gain during pregnancy. In some cases, it may become necessary to supplement with insulin during pregnancy. However, insulin treatment is associated with personal, health-related, and healthcare cost-related implications. The rationale for this study is the lack of knowledge regarding whether the extent of support and guidance from a dietitian during pregnancy has an impact on the treatment outcomes for both the mother and the child in cases of GDM. The overall objective is to investigate differences in clinical, cost-related, and patient-reported outcomes between women with GDM randomised to either intensive dietary therapy or standard dietary care (control). The primary endpoint is the effect of intensive dietary therapy on the likelihood of remaining treated with diet only vs. needing insulin therapy. The study design is a randomised controlled parallel group open-label effectiveness trial including 214 women with GDM.

Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes

The goal of this clinical trial is to examine the effect of 3 versus 6 daily meals of isocaloric diets on glycemic control and variability in individuals with type 1 diabetes. Participants will be randomized in a crossover clinical trial and will receive two different types of isocaloric diet interventions, in 3 meals/day (calorie distribution: 30% at breakfast, 40% at lunch and 30% at dinner) or 6 meals/day (calorie distribution: 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 25% at dinner and 5% at evening snack), for three weeks, with a 4-week washout period between diets.

Bionenergetic Balance During CVVH

The bioenergetic balance is the sum of energy exchanged during CRRT and is mostly defined by citrate glucose and lactate. When CRRT was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). During continuous venovenous hemofiltration (CVVH), a subgroup of CRRT which is performed with the newer dialysis fluids without lactate or glucose as advocated by the KDIGOguidelines, glucose and in a minor way lactate mostly induce a loss of energy. The first aim is to determine how this bioenergetic balance impacts energy need compared to the measured energy with indirect calorimetry and how nutrition therapy needs to be adapted. Also, disease specific predicting equation have been created for patients suffering from acute kidney injury treated with renal replacement therapy. How this predicting equation and other existing predicting equations agree with the measured REE has not been validated yet. The second aim is to determine how predictive equations correlate with measured REE in patients treated with CVVH.