Primary Objective: To investigate the effect of food order on postprandial blood glucose levels in children with type 1 diabetes, using 2 isocaloric meals. A standard meal with all macronutrients (carbohydrates, proteins and fat) combined will be…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in peak glucose level in the 3-hour clinical observation period
following the standard and test meal.
Secondary outcome
Glucose excursion at each 30-minute intervals from baseline till 180 minutes
after each meal, number of hypoglycaemic events (blood glucose level < 3.8
mmol/l) in the 3-hour clinical observation period following the meals, time to
peak glucose level and the proportion of time blood glucose level exceeded 10
mmol/l.
Background summary
Postprandial hyperglycaemia is associated with long-term diabetic complications
and mortality. Improving postprandial blood glucose levels might result in a
reduction in long-term diabetic complications. The order of consumption of
carbohydrates, proteins and fat * and therefore food order * has a significant
impact on postprandial blood glucose levels in adults with type 2 diabetes due
to delayed gastric emptying, changes in hormonal gastrointestinal response and
regulatory peptides. Based on the available data and possible
pathophysiological mechanisms in adults with type 2 diabetes, patients with
type 1 diabetes might also respond with lower postprandial blood glucose levels
when food order is changed. Our hypothesis is that postprandial blood glucose
levels will be lower when carbohydrates are consumed after fat and proteins,
compared to a meal where all macronutrients are combined (a standard meal).
Study objective
Primary Objective: To investigate the effect of food order on postprandial
blood glucose levels in children with type 1 diabetes, using 2 isocaloric
meals. A standard meal with all macronutrients (carbohydrates, proteins and
fat) combined will be compared to a meal where proteins and fat are consumed 15
minutes prior to carbohydrates (test meal).
Secondary Objective(s): To assess the additional value of CGMS versus 30-minute
capillary blood glucose levels to determine the course of blood glucose levels.
Study design
Randomized, open-labelled, within-subject repeated measures crossover study.
Intervention
Patients will be served 2 meals, separated by 2-3 days. During the standard
meal all macronutrients will be consumed together. During the test meal,
proteins and fat are separated from the carbohydrate part of the meal. Patients
will consume the protein and fat part of the meal first, followed by the
carbohydrate part of the meal 15 minutes afterwards.
Study burden and risks
A CGM sensor will be inserted in the abdominal subcutaneous tissue and a
physical examination will be performed 1 day prior to study entry. CGMS is
considered standard of care for patients on pump treatment and the burden can
be regarded as minimal. CGMS requires 2 times per day capillary blood glucose
measurements to allow for calibration. These measurement are part of the daily
blood glucose checks performed by patients with type 1 diabetes. During the
study week, patients and their parent(s) will visit the daycare facility twice
for a period of approximately 4 hours. Half of the group will receive a
standard meal during the first visit, followed by the test meal 2-3 days later,
the other half will receive the test meal first. Capillary blood glucose levels
measured by the patient or their parent will be determined every 30 minutes
during the 3-hour postprandial period. During this period, patients will be
sedentary. The 30 minute interval finger pricks for determination of capillary
blood glucose levels is regarded as a negligible burden.
Leyweg 275
Den Haag 2545 CH
NL
Leyweg 275
Den Haag 2545 CH
NL
Listed location countries
Age
Inclusion criteria
- Children with type 1 diabetes who have been diagnosed for > 1 year.
- Age between 7 and 17 years.
- Glycated haemoglobin (HbA1c) <8.5% (69 mmol/mol).
- BMI < +1.8 Standard Deviation Score (SDS) for age.
Exclusion criteria
- Coexisting medical problems such as celiac disease.
- Thyroid function test last determined > 1 year ago.
- Dietary restrictions.
- Fasting blood glucose level > 10 mmol/l or < 3.8 mmol/l requiring intervention during the morning of study days.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | Aangemeld bij Nederlands Trial Register, nummer volgt binnen 4 weken. |
| CCMO | NL57065.098.16 |
| OMON | NL-OMON21988 |