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Does Protein and Fat Content of Meal Increase Glucose Concentrations

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calculation of insulin dosages for different meals
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Fat-protein counting, Type 1 diabetes, Postprandial glucose level

Eligibility Criteria

16 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Insulin dose-CARB counting HPM group

    Insulin dose-CARB counting HPFM group

    Insulin dose-CARB+FPU counting-HPFM

    Insulin dose-CARB counting SM group

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 26, 2017
    Last Updated
    November 2, 2017
    Sponsor
    TC Erciyes University
    Collaborators
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03333525
    Brief Title
    Does Protein and Fat Content of Meal Increase Glucose Concentrations
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 10, 2013 (Actual)
    Primary Completion Date
    February 20, 2014 (Actual)
    Study Completion Date
    February 20, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University
    Collaborators
    Hacettepe University

    4. Oversight

    5. Study Description

    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 diabetes (T1D) on basal-bolus insulin therapy.
    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes Mellitus
    Keywords
    Fat-protein counting, Type 1 diabetes, Postprandial glucose level

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Insulin dose-CARB counting HPM group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Insulin dose-CARB counting HPFM group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Insulin dose-CARB+FPU counting-HPFM
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Insulin dose-CARB counting SM group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Calculation of insulin dosages for different meals
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change Postprandial Glucose Concentrations
    Description
    Change from baseline capillary blood glucose values at 240 min after control and test meals consumption.
    Time Frame
    0-240 minutes
    Secondary Outcome Measure Information:
    Title
    Postprandial insulin need
    Description
    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]

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31647139
    Citation
    Kaya N, Kurtoglu S, Gokmen Ozel H. Does meal-time insulin dosing based on fat-protein counting give positive results in postprandial glycaemic profile after a high protein-fat meal in adolescents with type 1 diabetes: a randomised controlled trial. J Hum Nutr Diet. 2020 Jun;33(3):396-403. doi: 10.1111/jhn.12711. Epub 2019 Oct 24.
    Results Reference
    derived

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