Does Protein and Fat Content of Meal Increase Glucose Concentrations

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333525
• Other study ID #: 2013/173
• Secondary ID: KEPANESPEN Trave
• Status: Completed
• Phase: N/A
• First received: October 26, 2017
• Last updated: November 2, 2017
• Start date: September 10, 2013
• Est. completion date: February 20, 2014

Study information

• Verified date: October 2017
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 20, 2014
• Est. primary completion date: February 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• Calculation 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
TC Erciyes University	Hacettepe University

Outcome

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