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Completed

NCT Number: NCT05271695

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Dietary Inflammatory Index (DII) Endocrine System Diseases Glucose Metabolism Disorders Inflammation Medical Nutrition Therapy Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Istanbul, Capa, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Current serum TNF-α value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

    Serum TNF-α values in the current nutritional status of patients with and without type 2 diabetes will be examined.

  2. Current serum IL-6 value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

    Serum IL-6values in the current nutritional status of patients with and without type 2 diabetes will be examined.

  3. Current serum IL-1β value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

    Serum IL-1β values in the current nutritional status of patients with and without type 2 diabetes will be examined.

  4. Current Dietary Inflammatory Index score

    Time frame: At the end of the 10-hour fasting of the patients, a single time

    The Dietary Inflammatory Index score of the current nutritional status of patients with and without type 2 diabetes will be evaluated. In this study, 31 foods and nutrients were determined from food consumption records. The amounts of nutrients were calculated using the nutrient analysis program. Dietary inflammatory index (DII) score was calculated from these foods.

    In order to calculate the diet inflammatory index score, the z-score must first be calculated. To calculate the Z-score, the standard global consumption amount is subtracted from the average consumption amount of the individual. The result obtained is divided by the standard deviation value. The z score found with this result is converted to the percentile score. The percentile value is multiplied by the full inflammatory effect score. DII is obtained as a result of summing the scores calculated for all nutrients and nutrients. Found DII is an indicator of the inflammatory load of the individual's daily diet.

Secondary outcomes

  1. Current serum glucose value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  2. Current serum HbA1c value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  3. Current waist circumference measurement

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  4. Current weight

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  5. Current BMI

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  6. Current fat mass rate

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  7. Current serum HDL value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  8. Current serum LDL value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  9. Current serum triglyceride value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  10. Current serum AST(aspartate aminotransferase) value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  11. Current serum urea value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  12. Current serum creatinin value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

  13. Current serum uric acid value

    Time frame: At the end of the 10-hour fasting of the patients, a single time

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2022
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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