Does Protein and Fat Content of Meal Increase Glucose Concentrations

NCT03333525 | Completed

• 3 other identifiers: 2013/173KEPANESPEN Travel Grant (36 th)
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change Postprandial Glucose Concentrations

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

  0-240 minutes

Secondary Outcomes (1)

• Postprandial insulin need

  [Time Frame: 0-240 minutes]

Study Arms (4)

Insulin dose-CARB counting HPM group

EXPERIMENTAL

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.

Other: Calculation of insulin dosages for different meals

Insulin dose-CARB counting HPFM group

EXPERIMENTAL

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.

Other: Calculation of insulin dosages for different meals

Insulin dose-CARB+FPU counting-HPFM

EXPERIMENTAL

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.

Other: Calculation of insulin dosages for different meals

Insulin dose-CARB counting SM group

ACTIVE COMPARATOR

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.

Other: Calculation of insulin dosages for different meals

Interventions

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.

Insulin dose-CARB counting HPFM group; Insulin dose-CARB counting HPM group; Insulin dose-CARB counting SM group; Insulin dose-CARB+FPU counting-HPFM

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• TC Erciyes University: lead
• Hacettepe University: collaborator

Related Publications (1)

• Kaya N, Kurtoglu S, Gokmen Ozel H. Does meal-time insulin dosing based on fat-protein counting give positive results in postprandial glycaemic profile after a high protein-fat meal in adolescents with type 1 diabetes: a randomised controlled trial. J Hum Nutr Diet. 2020 Jun;33(3):396-403. doi: 10.1111/jhn.12711. Epub 2019 Oct 24.

  PMID: 31647139 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, clinical research

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 7, 2017
• Study Start: September 10, 2013
• Primary Completion: February 20, 2014
• Study Completion: February 20, 2014
• Last Updated: November 7, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share