Effect of Dietary Inflammatory Index on Inflammatory Markers and Metabolic Parameters, in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT05271695

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-04-01

Brief Summary

Nutrition is essential in the treatment and management of Type 2 Diabetes. The importance of adding foods with anti-inflammatory effects to daily diet plans in ensuring glycemic control, preventing the progression of diabetes, and reducing the risk of complications in the future is revealed by new studies added to the literature every day. This study aimed to determine the effects of the dietary inflammatory index (DII) on inflammation markers and metabolic parameters by determining the food consumption status of adults with type 2 diabetes who have good glycemic control.

Detailed Description

Nutrition is one of the most important determinants of inflammation. When the results of the studies were examined, it was seen that the diet was associated with inflammation in chronic diseases. It was observed that the consumption of foods such as simple carbohydrates, red meat, saturated fat, and trans fat was associated with high Interleukin-6 (IL-6) levels, which had a pro-inflammatory effect. It has been observed that the consumption of foods such as green leaves, vegetables, fruits, olive oil, whole grains, and fish in the Mediterranean type diet is associated with low levels of inflammation with anti-inflammatory effects. It is known that anti-inflammatory dietary components are essential in preventing chronic diseases. "Diet Inflammatory Index (DII)" was developed to determine the inflammatory load of diets. DII, nutritional components, pro-inflammatory markers C-reactive protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 1 beta (IL-1β) and Interleukin 6 (IL-6) and anti-inflammatory markers Interleukin 10 (IL) -10) is an index provided by evaluating its effect on Interleukin 4 (IL-4). In order to obtain the inflammatory load of the diet, the impact of 45 nutritional parameters on inflammation is calculated. It is calculated as a positive score if the nutrient in the diet has a pro-inflammatory (increasing inflammation) effect and a negative score if it has an anti-inflammatory (reducing inflammation) effect.

Studies conducted with diabetes and DII have observed that feeding individuals with a pro-inflammatory diet cause them to have higher DII scores, higher HbA1c, and an increased risk of developing diabetes.

The primary purpose of this study is to find the relationship between the dietary inflammatory index and inflammatory markers in adult type 2 diabetes patients and to determine whether DII is a valid index in adult type 2 diabetes patients.

The second aim is to evaluate the relationship between DII scores and metabolic parameters in adult type 2 diabetes patients.

With the possible results, it aims to determine the measures to be taken to reduce the chronic inflammatory response due to nutritional status in type 2 diabetes patients and prevent the occurrence of diabetes-related complications.

Conditions

Type 2 Diabetes; Dietary Inflammatory Index (DII); Inflammation; Medical Nutrition Therapy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

The patients with type 2 diabetes

• Patients with a diagnosis of Type 2 Diabetes Mellitus and HbA1c ≤ 7%
• Patients using or not using oral antidiabetic drugs
• Patients who inject insulin once or twice a day or repeated insulin injections

No interventions assigned to this group

The healthy controls

• Patients diagnosed with Type I Diabetes Mellitus,
• Patients with HbA1c > 7%
• Those with gestational diabetes,
• Breastfeeding diabetics,
• Patients with renal dysfunction,
• Patients with acute and chronic infection status

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with a diagnosis of Type 2 Diabetes Mellitus and HbA1c ≤ 7%
• Patients using or not using oral antidiabetic drugs
• Patients who inject insulin once or twice a day or repeated insulin injections

Exclusion Criteria

• Patients diagnosed with Type I Diabetes Mellitus,
• Patients with HbA1c > 7%
• Those with gestational diabetes,
• Breastfeeding diabetics,
• Patients with renal dysfunction,
• Patients with acute and chronic infection status

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Fulya Calikoglu

MD, PhD; Academician; Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism

Istanbul, Capa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

2019/732

Identifier Type: -

Identifier Source: org_study_id