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OpenTrials
Completed

NCT Number: NCT03333525

Does Protein and Fat Content of Meal Increase Glucose Concentrations

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Calculation of insulin dosages for different meals

Other

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 outcomes

  1. Change Postprandial Glucose Concentrations

    Time frame: 0-240 minutes

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

Secondary outcomes

  1. Postprandial insulin need

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

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

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Collaborators

  • Hacettepe University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2017
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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