Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-06 @ 3:01 PM
Study NCT ID:
NCT05271695
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2022-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dietary Inflammatory Index on Inflammatory Markers and Metabolic Parameters, in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-27', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-02-27', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Current serum TNF-α value', 'timeFrame': 'At the end of the 10-hour fasting of the patients, a single time', 'description': 'Serum TNF-α values in the current nutritional status of patients with and without type 2 diabetes will be examined.'}, {'measure': 'Current serum IL-6 value', 'timeFrame': 'At the end of the 10-hour fasting of the patients, a single time', 'description': 'Serum IL-6values in the current nutritional status of patients with and without type 2 diabetes will be examined.'}, {'measure': 'Current serum IL-1β value', 'timeFrame': 'At the end of the 10-hour fasting of the patients, a single time', 'description': 'Serum IL-1β values in the current nutritional status of patients with and without type 2 diabetes will be examined.'}, {'measure': 'Current Dietary Inflammatory Index score', 'timeFrame': 'At the end of the 10-hour fasting of the patients, a single time', 'description': "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.\n\nIn 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."}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary inflammatory index (DII)', 'Inflammation', 'Type 2 diabetes', 'inflammatory markers', 'biochemical parameters'], 'conditions': ['Type 2 Diabetes', 'Dietary Inflammatory Index (DII)', 'Inflammation', 'Medical Nutrition Therapy']}, 'referencesModule': {'references': [{'pmid': '26706026', 'type': 'BACKGROUND', '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.'}, {'pmid': '19864399', 'type': 'BACKGROUND', 'citation': 'Cavicchia PP, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Hebert 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.'}, {'pmid': '23941862', 'type': 'BACKGROUND', 'citation': 'Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert 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.'}, {'pmid': '25871645', 'type': 'BACKGROUND', 'citation': 'Wirth MD, Shivappa N, Steck SE, Hurley TG, Hebert 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.'}, {'pmid': '27144647', 'type': 'BACKGROUND', '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.'}, {'pmid': '31704748', 'type': 'BACKGROUND', '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.'}, {'pmid': '29302846', 'type': 'BACKGROUND', '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.'}, {'pmid': '32425449', 'type': 'BACKGROUND', '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.'}, {'pmid': '28750216', 'type': 'BACKGROUND', '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.'}, {'pmid': '31611148', 'type': 'BACKGROUND', '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.'}, {'pmid': '24910231', 'type': 'BACKGROUND', '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.'}, {'pmid': '17943769', 'type': 'BACKGROUND', 'citation': 'Robertson L, Waugh N, Robertson A. Protein restriction for diabetic renal disease. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD002181. doi: 10.1002/14651858.CD002181.pub2.'}, {'pmid': '29897866', 'type': 'BACKGROUND', 'citation': 'Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez 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.'}, {'pmid': '27379574', 'type': 'BACKGROUND', '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.'}, {'pmid': '22275443', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '31434641', 'type': 'BACKGROUND', '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.'}, {'pmid': '27803762', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1155/2016/5276130. Epub 2016 Oct 10.'}, {'pmid': '27478547', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nStudies 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.\n\nThe 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.\n\nThe second aim is to evaluate the relationship between DII scores and metabolic parameters in adult type 2 diabetes patients.\n\nWith 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of Type 2 Diabetes Mellitus and HbA1c ≤ 7%\n* Patients using or not using oral antidiabetic drugs\n* Patients who inject insulin once or twice a day or repeated insulin injections\n\nExclusion Criteria:\n\n* Patients diagnosed with Type I Diabetes Mellitus,\n* Patients with HbA1c \\> 7%\n* Those with gestational diabetes,\n* Breastfeeding diabetics,\n* Patients with renal dysfunction,\n* Patients with acute and chronic infection status'}, 'identificationModule': {'nctId': 'NCT05271695', 'briefTitle': 'Effect of Dietary Inflammatory Index on Inflammatory Markers and Metabolic Parameters, in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Effect of Dietary Inflammatory Index on Inflammatory Markers and Metabolic Parameters, in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '2019/732'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The patients with type 2 diabetes', 'description': '* Patients with a diagnosis of Type 2 Diabetes Mellitus and HbA1c ≤ 7%\n* Patients using or not using oral antidiabetic drugs\n* Patients who inject insulin once or twice a day or repeated insulin injections'}, {'label': 'The healthy controls', 'description': '* Patients diagnosed with Type I Diabetes Mellitus,\n* Patients with HbA1c \\> 7%\n* Those with gestational diabetes,\n* Breastfeeding diabetics,\n* Patients with renal dysfunction,\n* Patients with acute and chronic infection status'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Capa', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD; Academician; Principle Investigator', 'investigatorFullName': 'Fulya Calikoglu', 'investigatorAffiliation': 'Istanbul University'}}}}