Effect of High Fat High Protein Meal in Type 1 Diabetes (T1DM-HFHP)

Cumhuriyet University

Status: Completed

Conditions: Type 1 Diabetes Mellitus; Adolescent

Treatments: 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT07158385

17-AKD-195

Details and patient eligibility

About

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.

Full description

This study is designed as a single-center, randomized, controlled, single-blind study on insulin. Eleven adolescents aged 12-18 years receiving continuous subcutaneous insulin infusion (CSII) were administered a 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 6-hour postprandial glucose responses using continuous glucose monitoring system (CGMS). The standard meal contained 58.6 g carbohydrate, 16.9 g protein, 14.8 g fat, while the high-fat high-protein meal contained 58.2 g carbohydrate, 32.4 g protein, 30.4 g fat. 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. Additionally, 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. 6-hour postprandial plasma glucagon, FFA, and GLP-1 levels were compared after the standard meal and the high-fat-high-protein meal. Early (0-120 min), late (120-360 min), and total (0-360 min) total area under the curve (tAUC) method was used to compare glucagon, GLP-1 and free fatty acid levels.

Enrollment: 11 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Clinical group

Experimental group

Description:

Each participant attended all 4 test meals

Treatment:

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

Other: High fat high protein meal-fat counting (HFHP-a)

Other: High fat high protein meal-carbohydrate counting (HFHP)

Other: Standard test meal (SM)