Does Protein and Fat Content of Meal Increase Glucose Concentrations

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Calculation of insulin dosages for different meals

• Registration Number: NCT03333525
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Study Start: 2013-09-10
• Primary Completion: 2014-02-20
• Study Completion: 2014-02-20
• Status Verified: 2017-10
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-02
• Last Update Submitted: 2017-11-02
• Study First Posted: 2017-11-07
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin dose-CARB+FPU counting-HPFM	Calculation of insulin dosages for different meals	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.
Insulin dose-CARB counting HPM group	Calculation of insulin dosages for different meals	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.
Insulin dose-CARB counting HPFM group	Calculation of insulin dosages for different meals	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.
Insulin dose-CARB counting SM group	Calculation of insulin dosages for different meals	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.