Status:
COMPLETED
Does Protein and Fat Content of Meal Increase Glucose Concentrations
Lead Sponsor:
TC Erciyes University
Collaborating Sponsors:
Hacettepe University
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
16-18 years
Phase:
NA
Brief Summary
The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients with type 1 di...
Detailed Description
In this single center, crossover, randomized, controlled study, control meal (SM: standard meal using carbohydrate counting method) and three test meals (HPM: high protein meal using carbohydrate coun...
Eligibility Criteria
Inclusion
- Subjects:
- had Type1 Diabetes for at least 1 years;
- use multiple dose (basal-bolus) insulin therapy;
- use fast-acting insulin analogs (lispro, glulisine, and aspart) and basal insulin analogs (detemir, glargine);
- daily inslin dose ≥0.5 IU/kg/day.
Exclusion
- Subjects:
- had any restrictive food intake disorders (eg celiac disease or food allergy);
- had any diabetes complications (eg neuropathy, nephropathy or retinopathy);
- diagnosed for \<1 year;
- were using corticosteroid or any medication that could effect gastric emptying;
- did exercise or had hypoglycemia or ketoacidosis within 24 hour before the test meals;
- had overweight or obese (BMI z score: ≥ 1SD and ≥ 2SD respectively);
- had not on follicular or peri-ovulatory phases of their menstrual cycles (for females).
Key Trial Info
Start Date :
September 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03333525
Start Date
September 10 2013
End Date
February 20 2014
Last Update
November 7 2017
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