NCT07158385: T1DM-HFHP

Effect of High Fat High Protein Meal in Type 1 Diabetes

Completed NA Last updated 5 September 2025

What this trial tests

NA trial testing Standard test meal (SM) in Type 1 Diabetes Mellitus in 11 participants. Completed in 17 February 2021.

Timeline

1 January 2019

Primary endpoint
30 October 2019

17 February 2021

Quick facts

Lead sponsor	Cumhuriyet University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	11
Start date	1 January 2019
Primary completion	30 October 2019
Estimated completion	17 February 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

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

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
• Adolescent — all drugs for Adolescent →

Sponsor

Cumhuriyet University

Who can join

Adults 12 to 18, any sex, with Type 1 Diabetes Mellitus or Adolescent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.