Clinical trial NCT05271695: Effect of Dietary Inflammatory Index on Inflammatory Markers and Metabolic Parameters, in Patients With Type 2 Diabetes Mellitus
Official title: Effect of Dietary Inflammatory Index on Inflammatory Markers and Metabolic Parameters, in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Current serum TNF-α value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum IL-6 value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum IL-1β value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current Dietary Inflammatory Index score
timeFrame: At the end of the 10-hour fasting of the patients, a single time
Secondary outcomes:
measure: Current serum glucose value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum HbA1c value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current waist circumference measurement
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current weight
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current BMI
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current fat mass rate
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum HDL value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum LDL value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum triglyceride value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum AST(aspartate aminotransferase) value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum urea value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum creatinin value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
measure: Current serum uric acid value
timeFrame: At the end of the 10-hour fasting of the patients, a single time
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism
state: Capa
Study officials:
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