Does Protein and Fat Content of Meal Increase Glucose Concentrations

TC Erciyes University30 enrolled

Overview

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 diabetes (T1D) on basal-bolus insulin therapy.

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 counting method, HPFM-a: high protein-fat meal using carbohydrate counting method and HPFM-b: high protein-fat meal using carbohydrate and fat-protein counting method) were compared on postprandial early (0-120 minutes), late (120-240 minutes) and total (0-240 minutes) glucose response.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

Calculation of insulin dosages for different mealsOTHER

Calculation of insulin dosages For CARB counting meals using insulin-carbohydrate ratio for dosing mealtime boluses. For fat protein counting meal ICR and additionally fat-protein unit were used for dosing of mealtime boluses.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 Criteria: 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).

Outcomes

Primary Outcomes

Change Postprandial Glucose Concentrations

Change from baseline capillary blood glucose values at 240 min after control and test meals consumption.

Time frame: 0-240 minutes

Secondary Outcomes

Postprandial insulin need

Insulin dosage was calculated by FPU (is defined as 100 calories of fat and protein) for HFPM-b meal.

Time frame: [Time Frame: 0-240 minutes]

Data from ClinicalTrials.gov

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