Status:
RECRUITING
Effect of Intensive Nutrition Training, Education, and Support in Gestational Diabetes - The INTENSE-GDM TRIAL
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Herlev Hospital
Rigshospitalet, Denmark
Conditions:
GDM
Gestational Diabetes
Eligibility:
FEMALE
Phase:
NA
Brief Summary
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 m...
Detailed Description
Gestational diabetes (GDM) is defined as glucose intolerance with onset or first recognition during pregnancy. The disease is characterized by hyperglycaemia and a marked insulin resistance secondary ...
Eligibility Criteria
Inclusion
- Newly diagnosed women with GDM referred to Department of Obstetrics Herlev Hospital
- Women diagnosed with GDM based on 2-hour OGTT plasma glucose value ≥ 9.0 mmol/l
- Women diagnosed with GDM based on at least 2 plasma glucose measurements above targets (either pre-prandial ≥6.0 mmol/l, or 2-hours postprandial ≥8.0 mmol/l)
- GA at GDM diagnosis ≤ 34
- Women with an estimated probability of ≥20% for initiating insulin treatment during pregnancy. The estimated probability is based on a logistic regression model developed at SDCC and includes the following variables: prepregnancy BMI, GA at GDM diagnosis, and HbA1c at GDM diagnosis. In cases where HbA1c has not been measured during the initial visit with the dietitian (screening visit), prepregnancy BMI, GA at the time of diagnosis and 2H OGTT will be used to estimate the probability of initiating insulin therapy.
- Provided voluntary written informed parental consent in Danish or English or after translation by an interpreter for non-Danish and non-English speaking parents
Exclusion
- Bariatric surgery
- Other intercurrent illness (e.g., cancer, ulcerative colitis) as judged by medical experts
- Uncontrolled medical issues, as judged by medical experts
- Concomitant participation in other clinical trials that could interfere with the INTENSE- GDM Trial as evaluated by the principle investigator
- Unable to understand the informed consent/procedures regardless of spoked language
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT06127823
Start Date
January 3 2024
End Date
December 31 2025
Last Update
June 3 2024
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Herlev, Denmark, DK-2730