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

February 27, 2022 updated by: Fulya Calikoglu, Istanbul University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Capa
      • Istanbul, Capa, Turkey, 34093
        • Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study was selected among adult type 2 diabetes patients under control at Istanbul University Istanbul Medical Faculty Diabetes Polyclinic between November 2019 and April 2020. The 120 patients included studying were between the ages of 30-74 and were sent to the diet polyclinic by their physicians. As the control group, 30 healthy people from the same age group were included. The data were collected by the researcher by face-to-face interview.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the 10-hour fasting of the patients, a single time
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.
At the end of the 10-hour fasting of the patients, a single time
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.
At the end of the 10-hour fasting of the patients, a single time
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.
At the end of the 10-hour fasting of the patients, a single time

Secondary Outcome Measures

Outcome Measure
Time Frame
Current serum glucose value
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current serum HbA1c value
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current waist circumference measurement
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current weight
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current BMI
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current fat mass rate
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current serum HDL value
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current serum LDL value
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current serum triglyceride value
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current serum AST(aspartate aminotransferase) value
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current serum urea value
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current serum creatinin value
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time
Current serum uric acid value
Time Frame: At the end of the 10-hour fasting of the patients, a single time
At the end of the 10-hour fasting of the patients, a single time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

February 27, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 27, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/732

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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