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

NCT05271695 | Completed

• 1 other identifier: 2019/732
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dietary inflammatory index (DII); Inflammation; Type 2 diabetes; inflammatory markers; biochemical parameters

Outcome Measures

Primary Outcomes (4)

• Current serum TNF-α value

  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

  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

  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

  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 Outcomes (13)

• Current serum glucose value

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

• Current serum HbA1c value

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

• Current waist circumference measurement

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

• Current weight

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

• Current BMI

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

Study Arms (2)

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

Eligibility Criteria

• Age: 30 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

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

Istanbul, Capa, 34093, Turkey (Türkiye)

Location

Related Publications (18)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD; Academician; Principle Investigator

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 9, 2022
• Study Start: November 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

TU (1)