Does Protein and Fat Content of Meal Increase Glucose Concentrations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does High-Protein High-Fat Meal Increase Postprandial Glucose Concentrations and Meal-Time Insulin Requirements in Patients With Type 1 Diabetes on Basal-Bolus Insulin Regimen: A Randomized Controlled Trial

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: Calculation of insulin dosages for different meals


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin dose-CARB counting HPM group<br>HPM (high protein meal), contained 36 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. | Other: Calculation of insulin dosages for different meals<br>* 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.<br>|
| Experimental: Insulin dose-CARB counting HPFM group<br>HPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. | Other: Calculation of insulin dosages for different meals<br>* 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.<br>|
| Experimental: Insulin dose-CARB+FPU counting-HPFM<br>HPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting plus fat-protein counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. | Other: Calculation of insulin dosages for different meals<br>* 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.<br>|
| Active Comparator: Insulin dose-CARB counting SM group<br>SM (standart meal), contained 24 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes. | Other: Calculation of insulin dosages for different meals<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Postprandial Glucose Concentrations | Change from baseline capillary blood glucose values at 240 min after control and test meals consumption. | 0-240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial insulin need | Insulin dosage was calculated by FPU (is defined as 100 calories of fat and protein) for HFPM-b meal. | [Time Frame: 0-240 minutes] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fat-protein counting, Type 1 diabetes, Postprandial glucose level