Impact of type 1 diabetes mellitus and celiac disease on nutrition and quality of life.
J G Nunes-Silva, V S Nunes, R P Schwartz...
https://pubmed.ncbi.nlm.nih.gov/28067892/Actively Recruiting
Led by University of Pecs · Updated on 2025-01-22
190
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are investigating the key cardiovascular risk factors, including metabolic parameters and body composition, in people with coeliac disease CD. This research focuses on newly diagnosed and treated CD patients to understand how these factors change over time, especially during a gluten-free diet GFD. The study also evaluates whether a structured dietary intervention can reduce negative effects associated with an unbalanced diet in these patients. The study includes a randomized controlled trial where participants are assigned either to a dietary intervention group receiving structured, group-based online dietary counseling focused on maintaining a GFD and adopting a Mediterranean diet, or to a standard care group receiving baseline dietary education. The counseling consists of six sessions over one year, with monthly meetings for five months and a final session at month nine. The study also collects detailed data on body composition and cardiovascular risk markers. Participants will undergo various assessments including body composition measurement, questionnaires on symptoms, quality of life, and diet adherence, blood tests for metabolic and immunological parameters, urine tests for gluten intake, and ultrasound scans to check for fatty liver disease. These evaluations occur over one year to monitor changes in percent body fat and other health markers. The study aims to improve understanding of metabolic and cardiovascular health in CD and to optimize follow-up care.
CONDITIONS
Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies
J
Judit Bajor, MD, PhD
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University of Pecs
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants are randomized to receive either structured, group-based online dietary counseling sessions or standard of care with baseline dietary education. The counseling aims to maintain a gluten-free diet and promote a healthy lifestyle aligned with the Mediterranean diet.
6 online group counseling sessions over 1 year (monthly for 5 months and one at month 9)
Duration - 1 year
Participants undergo anthropometric measurements, questionnaires, urine and blood collection, and ultrasound examinations to assess body composition, dietary adherence, cardiovascular risk factors, and liver health throughout the study.
Multiple assessments including questionnaires, blood and urine collection, and ultrasound at baseline and follow-up visits during the 1-year study
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Lead Sponsor