Does Protein and Fat Content of Meal Increase Glucose Concentrations

TC Erciyes University

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Other: Calculation of insulin dosages for different meals

Study type: Interventional

Funder types: Other

Identifiers

NCT03333525

KEPAN (Other Grant/Funding Number)

2013/173

ESPEN Travel Grant (36 th) (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 16 to 18 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

Insulin dose-CARB counting HPM group

Experimental group

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.

Treatment:

Other: Calculation of insulin dosages for different meals

Insulin dose-CARB counting HPFM group

Experimental group

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.

Treatment:

Other: Calculation of insulin dosages for different meals

Insulin dose-CARB+FPU counting-HPFM

Experimental group

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.

Treatment:

Other: Calculation of insulin dosages for different meals

Insulin dose-CARB counting SM group

Active Comparator group

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.

Treatment:

Other: Calculation of insulin dosages for different meals