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AzTrials

Type 2 DiabetesNCT05271695

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

An observational study of Type 2 Diabetes and Dietary Inflammatory Index (DII), run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 30 to 74 yearsHealthy volunteers can take part
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2019to 1 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Istanbul, Capa, 34093

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Keywords
Dietary inflammatory index (DII), Inflammation, Type 2 diabetes, inflammatory markers, biochemical parameters
Medical subject headings
Diabetes Mellitus, Type 2, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05271695
Study groupRoleWhat they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Current serum IL-6 value

    Serum IL-6values in the current nutritional status of patients with and without type 2 diabetes will be examined.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes (13)

  1. Current serum glucose value

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

  2. Current serum HbA1c value

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

  3. Current waist circumference measurement

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

  4. Current weight

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

  5. Current BMI

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

  6. Current fat mass rate

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

  7. Current serum HDL value

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

  8. Current serum LDL value

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

  9. Current serum triglyceride value

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

  10. Current serum AST(aspartate aminotransferase) value

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

  11. Current serum urea value

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

  12. Current serum creatinin value

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

  13. Current serum uric acid value

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start1 Nov 2019
  3. Primary completion1 Apr 2020
  4. Study completion1 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05271695
Sponsor's protocol ID
2019/732
Status last verified
Feb 2022
First submitted
17 Feb 2022
Last updated
9 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26706026

  • 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.

    PubMed 19864399

  • 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.

    PubMed 23941862

  • 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.

    PubMed 25871645

  • 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.

    PubMed 27144647

  • 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.

    PubMed 31704748

  • 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.

    PubMed 29302846

  • 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.

    PubMed 32425449

  • 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.

    PubMed 28750216

  • 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.

    PubMed 31611148

  • 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.

    PubMed 24910231

  • 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.

    PubMed 17943769

  • 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.

    PubMed 29897866

  • 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.

    PubMed 27379574

  • 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.

    PubMed 22275443

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes and Dietary Inflammatory Index (DII), run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Current serum TNF-α value (time frame: At the end of the 10-hour fasting of the patients, a single time). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05271695, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.

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