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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271695
• Other study ID #: 2019/732
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: February 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inflammation
• Medical Nutrition Therapy
• Type 2 Diabetes

Locations

Country	Name	City	State
Turkey	Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism	Istanbul	Capa

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (18)

Arulselvan P, Fard MT, Tan WS, Gothai S, Fakurazi S, Norhaizan ME, Kumar SS. Role of Antioxidants and Natural Products in Inflammation. Oxid Med Cell Longev. 2016;2016:5276130. Epub 2016 Oct 10. Review. — View Citation

Benson G, Hayes J. An Update on the Mediterranean, Vegetarian, and DASH Eating Patterns in People With Type 2 Diabetes. Diabetes Spectr. 2020 May;33(2):125-132. doi: 10.2337/ds19-0073. — View Citation

Brown TJ, Brainard J, Song F, Wang X, Abdelhamid A, Hooper L; PUFAH Group. Omega-3, omega-6, and total dietary polyunsaturated fat for prevention and treatment of type 2 diabetes mellitus: systematic review and meta-analysis of randomised controlled trials. BMJ. 2019 Aug 21;366:l4697. doi: 10.1136/bmj.l4697. — View Citation

Cavicchia PP, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Hébert JR. A new dietary inflammatory index predicts interval changes in serum high-sensitivity C-reactive protein. J Nutr. 2009 Dec;139(12):2365-72. doi: 10.3945/jn.109.114025. Epub 2009 Oct 28. — View Citation

Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Fitó M, Gea A, Hernán MA, Martínez-González MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13. — View Citation

King DE, Xiang J. The Dietary Inflammatory Index Is Associated With Diabetes Severity. J Am Board Fam Med. 2019 Nov-Dec;32(6):801-806. doi: 10.3122/jabfm.2019.06.190092. — View Citation

Kirkpatrick CF, Bolick JP, Kris-Etherton PM, Sikand G, Aspry KE, Soffer DE, Willard KE, Maki KC. Review of current evidence and clinical recommendations on the effects of low-carbohydrate and very-low-carbohydrate (including ketogenic) diets for the management of body weight and other cardiometabolic risk factors: A scientific statement from the National Lipid Association Nutrition and Lifestyle Task Force. J Clin Lipidol. 2019 Sep - Oct;13(5):689-711.e1. doi: 10.1016/j.jacl.2019.08.003. Epub 2019 Sep 13. Review. — View Citation

Kizil M, Tengilimoglu-Metin MM, Gumus D, Sevim S, Turkoglu I, Mandiroglu F. Dietary inflammatory index is associated with serum C-reactive protein and protein energy wasting in hemodialysis patients: A cross-sectional study. Nutr Res Pract. 2016 Aug;10(4):404-10. doi: 10.4162/nrp.2016.10.4.404. Epub 2016 Mar 29. — View Citation

Ley SH, Hamdy O, Mohan V, Hu FB. Prevention and management of type 2 diabetes: dietary components and nutritional strategies. Lancet. 2014 Jun 7;383(9933):1999-2007. doi: 10.1016/S0140-6736(14)60613-9. Review. — View Citation

McGeoghegan L, Muirhead CR, Almoosawi S. Association between an anti-inflammatory and anti-oxidant dietary pattern and diabetes in British adults: results from the national diet and nutrition survey rolling programme years 1-4. Int J Food Sci Nutr. 2015 Aug;67(5):553-61. doi: 10.1080/09637486.2016.1179268. Epub 2016 May 4. — View Citation

Meng Y, Bai H, Wang S, Li Z, Wang Q, Chen L. Efficacy of low carbohydrate diet for type 2 diabetes mellitus management: A systematic review and meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2017 Sep;131:124-131. doi: 10.1016/j.diabres.2017.07.006. Epub 2017 Jul 8. Review. — View Citation

Robertson L, Waugh N, Robertson A. Protein restriction for diabetic renal disease. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD002181. Review. — View Citation

Schwingshackl L, Chaimani A, Hoffmann G, Schwedhelm C, Boeing H. A network meta-analysis on the comparative efficacy of different dietary approaches on glycaemic control in patients with type 2 diabetes mellitus. Eur J Epidemiol. 2018 Feb;33(2):157-170. doi: 10.1007/s10654-017-0352-x. Epub 2018 Jan 4. — View Citation

Shivappa N, Steck SE, Hurley TG, Hussey JR, Hébert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14. — View Citation

Steckhan N, Hohmann CD, Kessler C, Dobos G, Michalsen A, Cramer H. Effects of different dietary approaches on inflammatory markers in patients with metabolic syndrome: A systematic review and meta-analysis. Nutrition. 2016 Mar;32(3):338-48. doi: 10.1016/j.nut.2015.09.010. Epub 2015 Oct 28. Review. — View Citation

Wang DD, Li Y, Chiuve SE, Stampfer MJ, Manson JE, Rimm EB, Willett WC, Hu FB. Association of Specific Dietary Fats With Total and Cause-Specific Mortality. JAMA Intern Med. 2016 Aug 1;176(8):1134-45. doi: 10.1001/jamainternmed.2016.2417. — View Citation

Wheeler ML, Dunbar SA, Jaacks LM, Karmally W, Mayer-Davis EJ, Wylie-Rosett J, Yancy WS Jr. Macronutrients, food groups, and eating patterns in the management of diabetes: a systematic review of the literature, 2010. Diabetes Care. 2012 Feb;35(2):434-45. doi: 10.2337/dc11-2216. Review. — View Citation

Wirth MD, Shivappa N, Steck SE, Hurley TG, Hébert JR. The dietary inflammatory index is associated with colorectal cancer in the National Institutes of Health-American Association of Retired Persons Diet and Health Study. Br J Nutr. 2015 Jun 14;113(11):1819-27. doi: 10.1017/S000711451500104X. Epub 2015 Apr 14. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current serum TNF-a value	Serum TNF-a 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
Primary	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
Primary	Current serum IL-1ß value	Serum IL-1ß 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
Primary	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	Current serum glucose value		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current serum HbA1c value		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current waist circumference measurement		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current weight		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current BMI		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current fat mass rate		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current serum HDL value		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current serum LDL value		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current serum triglyceride value		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current serum AST(aspartate aminotransferase) value		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current serum urea value		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current serum creatinin value		At the end of the 10-hour fasting of the patients, a single time
Secondary	Current serum uric acid value		At the end of the 10-hour fasting of the patients, a single time