Does Protein and Fat Content of Meal Increase Glucose Concentrations

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03333525

Enrollment

Registered

2017-11-07

Start date

2013-09-10

Completion date

2014-02-20

Last updated

2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Fat-protein counting, Type 1 diabetes, Postprandial glucose level

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.

Interventions

OTHERCalculation of insulin dosages for different meals

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 18 Years

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).

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026