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Completed

NCT Number: NCT01566110

Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial

Currently no consensus exists on the optimal way to manage asymptomatic patients with celiac disease (CD) and Type 1 diabetes (T1D). The impact of dietary treatment as it pertains to clinically relevant outcomes such as metabolic control, bone mineralization and wellbeing will be evaluated in this study. A randomized controlled study longitudinally evaluating HbA1c and glycemic excursions using continuous glucose monitoring will rigorously determine the impact of a gluten-free diet (GFD) on blood glucose variability in patients with T1D.

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Key information

Conditions

Celiac Disease Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Immune System Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet each of the following criteria for inclusion into the study:

  • Males and females age between 8 and 45 years.
  • Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D greater than 1 year.
  • CD screen positive (Positive TTG serology).
  • Presence of a positive duodenal biopsy for CD (Marsh score of 2 or greater).
  • Ability of the subject or a legally authorized representative to speak and read English or French.
  • Ability of the subject to participate in all aspects of this clinical trial.
  • Written informed consent must be obtained and documented, with assent of the child if <14 years of age.

Exclusion criteria

  • Prior diagnosis of CD.
  • Symptoms or other evidence of overt CD defined by at least one of:
  • CD symptoms using the Gastrointestinal Symptom Scale [GISS]
  • Impaired growth
  • Anemia
  • Presence of recurrent apthous ulcers (painful mouth ulcers involving mucous membranes) or dermatitis herpetiformis (blistering skin rash). Mouth or skin lesions known to be related to diagnosed herpes are not included in this exclusion criteria.
  • Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
  • Prior enrolment in the current study.
  • Concurrent enrolment in a longitudinal intervention study.
  • Previously diagnosed or treated osteoporosis.
  • Pregnancy or lactation.

Treatment and study plan

Gluten free diet

Dietary Supplement

Subjects assigned to the intervention group will receive a standardized dietary education intervention that will inform subjects and family members of the effects of gluten on the gastrointestinal tract and emphasize the need to adhere to a diet that is gluten-free. This intervention will be delivered by a dietician who is trained in celiac disease and gluten free diet.

Primary outcomes

  1. Metabolic Control

    Time frame: Change from Baseline over 1 year

    As a standard measure of diabetes control, HbA1c is assessed on a frequent and regular basis as recommended by the CDA 2008 guidelines in both pediatric and adult patients. HbA1c is synthesized throughout the cycle of a red blood cell and reflects the degree of chronic hyperglycemia present in patients with diabetes.

Secondary outcomes

  1. Hypoglycemic Episodes

    Time frame: Frequency over 12 months

    The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit. These will be classified as severe hypoglycemic episodes in subjects with normal hypoglycemic awareness.

  2. Continuous Glucose Monitoring

    Time frame: Baseline, 6 months and 12 months after randomization

    Data will be evaluated for data quality, overall mean glucose, overall variability of blood glucose, patterns of blood glucose excursion, and measures of quality of glycemic control.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

A Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Gluten-Free Diet in Patients With Asymptomatic Celiac Disease and Type 1 Diabetes, Celiac Disease and Diabetes - Dietary Intervention and Evaluation Trial (CD-DIET)

Acronym: CD-DIET

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2012
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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