Effect of High Fat High Protein Meal in Type 1 Diabetes

NCT07158385 | Completed

• 1 other identifier: 17-AKD-195
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Despite optimal glycemic control in individuals with type 1 diabetes, post-meal hyperglycemia remains a clinical challenge, and it has been identified as an independent risk factor for the development of long-term complications, including cardiovascular diseases. With the increasing use of continuous glucose monitoring systems, evidence has been obtained that traditional insulin dosing strategies are not sufficiently effective as the effects of meals with different macronutrient content on glycemic response are further illuminated. It is argued that relying solely on counting carbohydrates for achieving glycemic control is insufficient, and that proteins and fats can cause an increase in postprandial glycemic response. Therefore, it is necessary for Type 1 diabetics to determine insulin dosage based not only on carbohydrates, but also on the amount of fats and proteins in their meals. This study investigated the protein and fat counting in addition to carbohydrate counting on the postprandial blood glucose levels in adolescents with Type 1 diabetes and analyzed the effect of the dietary fat and protein on glucagon, glucagon-like peptide-1 (GLP-1) and free fatty acid (FFA) levels. Methods: In this single center, randomised controlled, single-blind study with regards to insulin, 11 adolescents aged 12-18 years using continuous subcutaneous insulin infusion (CSII) were given standard meal (SM), and three test meals (HFHP: high-fat-high-protein meal using carbohydrate counting; HFHP-a: high-fat-high-protein meal using carbohydrate and fat counting; HFHP-b: high-fat-high-protein meal using carbohydrate and fat-protein counting) to compare postprandial 6 hours glucose response using continuous glucose monitoring system (CGMS). Also postprandial plasma glucagon, FFA, and GLP-1 levels were compared for 6 hours after a standard meal and a high-fat-high-protein meal.

Conditions

Type 1 Diabetes Mellitus; Adolescent

Keywords

Type 1 diabetes; carbohydrate counting; fat protein counting; glycemic response

Outcome Measures

Primary Outcomes (4)

• Glucose response

  Glucose response was measured using continuous glucose monitoring system (CGMS). CGMS were extracted from the cases and transferred to the computer, and their analysis was performed by the researcher, taking into account the capillary blood sugar measurements in the diary. Early (0-120 min), late (120-360 min), and total (0-360 min) glycemic response for the standard and test meals were analyzed using the calculation of the "incremental area under the curve" (iAUC) method. In addition, TIR (time in range) (70-180 mg/dL) and TAR (time above range) (\>180 mg/dL) values obtained at early (0-120 min), late (120-360 min) and total (0-360 min) periods during the test meals of the participants were compared.

  For each intervention meal (4 interventions), participants' glucose response was assessed for 6 hours after the meals.

• Plasma GLP-1 measurement

  Venous blood samples were taken from two intervention meals, a standard meal (SM) and a high-fat high-protein meal (HFHP), and were evaluated using an ELISA kit. Mean values at time points and early (0-120 min), late (120-360 min), and total (0-360 min) area under the curve (tAUC) method was used to compare the GLP-1 levels.

  On the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal.

• Plasma glucagon measurement

  Venous blood samples were taken from two intervention meals, a standard meal (SM) and a high-fat high-protein meal (HFHP), and were evaluated using an ELISA kit. Mean values at time points and early (0-120 min), late (120-360 min), and total (0-360 min) area under the curve (tAUC) method was used to compare the glucagon levels.

  Venous blood samples taken with the inserted catheter on the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal.

• Plasma free fatty acid measurement

  Venous blood samples were taken from two intervention meals, a standard meal (SM) and a high-fat high-protein meal (HFHP), and were evaluated using an ELISA kit. Mean values at time points and early (0-120 min), late (120-360 min), and total (0-360 min) area under the curve (tAUC) method was used to compare the free fatty acid levels.

  On the test day just before (t=0th min) the standard meal (SM) and high-fat high-protein meal (HFHP), and at the 30th, 60th, 90th, 120th, 240th and 360th minutes after the meal.

Study Arms (1)

Clinical group

EXPERIMENTAL

Each participant attended all 4 test meals

Other: Standard test meal (SM); Other: High fat high protein meal-carbohydrate counting (HFHP); Other: High fat high protein meal-fat counting (HFHP-a); Other: High fat high protein meal-fat and protein counting (HFHP-b)

Interventions

Standard test meal (SM) OTHER

Participants were given a standard breakfast meal with a fat and protein content similar to their daily intake. Insulin was administered according to their individual carbohydrate-to-insulin ratio. On the test day, venous blood samples were collected from the catheter inserted for GLP-1, glucagon, and free fatty acid analysis immediately before the meal (t=0 minute) and at 30, 60, 90, 120, 240, and 360 minutes after the meal.

Also known as: Carb counting

Clinical group

High fat high protein meal-carbohydrate counting (HFHP) OTHER

On the high-fat, high-protein meal-carbohydrate counting test day (HFHP), participants were given a high-fat and high-protein breakfast. Insulin was administered according to the individual carbohydrate-to-insulin ratio. On the test day, venous blood samples were collected from the catheter inserted for GLP-1, glucagon, and free fatty acid analysis immediately before the meal (t=0 minute) and at 30, 60, 90, 120, 240, and 360 minutes after the meal.

Also known as: Carb counting

Clinical group

High fat high protein meal-fat counting (HFHP-a) OTHER

On the high-fat, high-protein meal-fat-counting test day (HFHP-a), participants were given a high-fat and protein breakfast. In addition to their individual carbohydrate/insulin ratio, insulin was administered based on fat counting (1 unit for every 15 g of fat after the first 15 g of fat in the meal). In this method, the insulin dose calculated based on their individual carbohydrate/insulin ratio was delivered via insulin pump as a standard bolus, while the insulin dose calculated based on their fat count was delivered as a 4 hour extended bolus.

Also known as: Carb and fat counting

Clinical group

High fat high protein meal-fat and protein counting (HFHP-b) OTHER

On the high-fat, high-protein meal-fat and protein counting test day (HFHP-b), participants were given a high-fat and protein breakfast. In addition to the individual carbohydrate/insulin ratio, insulin was administered according to the adapted Pankowska Algorithm (1 FPU for every 100 kcal after the first 200 kcal of the meal). In this method, the insulin dose calculated based on the individual carbohydrate/insulin ratio was delivered as a standard bolus by an insulin pump, while the insulin dose calculated based on the fat and protein count was delivered as a spread over 4 hours.

Also known as: Carb and fat-protein counting

Clinical group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• No chronic disease other than type 1 diabetes mellitus
• Receiving continuous insulin infusion pump therapy

You may not qualify if:

• The individual's insulin requirement is less than 0.5 IU/kg/day
• High HbA1c (\>8%)
• Presence of complications (Microalbuminuria, etc.)
• Presence of a comorbidity (Celiac disease, etc.)
• New initiation of CSII treatment (\<6 months)
• Living outside Ankara
• Parental and individual reluctance
• The individual refuses to donate blood during the test meals

Sponsors & Collaborators

• Cumhuriyet University: lead
• Hacettepe University: collaborator

Study Sites (1)

Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Nutrition and Dietetics

Sivas, Turkey (Türkiye)

Location

Related Publications (1)

• Smart CE, Evans M, O'Connell SM, McElduff P, Lopez PE, Jones TW, Davis EA, King BR. Both dietary protein and fat increase postprandial glucose excursions in children with type 1 diabetes, and the effect is additive. Diabetes Care. 2013 Dec;36(12):3897-902. doi: 10.2337/dc13-1195. Epub 2013 Oct 29.

  PMID: 24170749 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Qa-SNARE Proteins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Q-SNARE Proteins; SNARE Proteins; Membrane Fusion Proteins; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vesicular Transport Proteins

Study Officials

• Zeynep Alev Özön, MD, Prof.

  Hacettepe University

  STUDY CHAIR

• Hülya Gökmen Özel, Prof. Dr.

  Hacettepe University

  STUDY DIRECTOR

• Elmas Nazlı Gönç, MD, Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ayfer Alikaşifoğlu, MD, Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Oytun Portakal, Assoc. Prof. Dr.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant blinded for insulin administration
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Four different interventions were applied to the same individuals

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: January 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: February 17, 2021
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)