Type 2 Diabetes Clinical Trial
Official title:
Dietary Oxysterols and β-Cell Function Among African Americans
African Americans (AAs) have a higher risk of developing type 2 diabetes than the general population. AAs are also more likely to eat foods that contain cholesterol oxides/oxysterols. Dietary oxysterols can harm the cells that produce insulin and decrease insulin production. This pilot study seeks to determine if removing dietary oxysterols with a plant-based diet will improve insulin production and decrease the risk of type 2 diabetes among AAs.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Participants must be: 1. HbA1c: 5.7% - 7.0%: This HbA1c range reflects mild to moderate ß-cell dysfunction. 2. Self-identified AA: This group has higher rates of T2D than the general population. 3. Adults over18 years old: This age group is at higher risk of T2D. 4. Ability to read, understand and communicate effectively in English: All information about the study and instructions for the study protocol will be in English. 5. Committed to eating the allocated study diet for 12 weeks: This is important to ensure that the study protocol is followed, and the data collected from participants is meaningful/valid. 6. On stable medication dosages for the three months prior to recruitment: This is to avoid bias or confounding with new medications or dosages changes. 7. Able to safely store a week's supply of prepared meals: Participants will receive packages of prepared food that has to stored and last them for the following week. 8. Mentally competent and able to follow the study protocol and provide informed consent 9. Currently eating the Standard American diet: The baseline diet of the participants will be assessed and correlated their baseline serum 7-KC levels and HOMA2 Index of ß-cell function. Exclusion Criteria: Participants cannot: 1. Be pregnant or lactating: Fetuses and breast-feeding infants are a protected vulnerable group. The risk of involving them in research must outweigh the benefits, Hormonal levels and other factors in pregnant and lactating woman may confound study results. 2. Be taking statin medications or any other cholesterol lowering drugs or supplements: These medications may artificially lower serum cholesterol and oxysterol levels. 3. Be currently on a vegan, vegetarian, or any type of plant-based diet for the 3 months prior to recruitment: Participants currently on these diets may not see significant changes on the dietary interventions of the study protocol. 4. Be a current smoker: Smoking is a risk factor for oxidative stress - this could be an effect modifier or a confounding faction for this study. 5. Be on medications or supplements to lower blood glucose or treat diabetes: This will be an effect modifier or confounding factor. We will not know the effect of the dietary intervention if the participants are also on medications for diabetes. 6. Be status post blood transfusion in the previous 3 months: This will interfere with the test for HbA1c levels. This is one of our primary outcomes: 7. Have a hemoglobin or any other blood disorder: This will interfere with the test for HBA1c which measures glycation of hemoglobin in red blood cells.: 8. Be taking biotin supplements: This interferes with the test for fasting C-Peptide. 9. Be on dialysis or have any stage of renal failure: Dialysis patients need special diets and more intense monitoring than is planned for the participants in this study. 10. Have food allergies: Participants will be screened for food allergies. This is to prevent food sensitivities or adverse reactions to the prepared meals in the study. |
Country | Name | City | State |
---|---|---|---|
United States | Morehouse School of Medicine | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Morehouse School of Medicine | Emory University |
United States,
Abderrahmani A, Niederhauser G, Favre D, Abdelli S, Ferdaoussi M, Yang JY, Regazzi R, Widmann C, Waeber G. Human high-density lipoprotein particles prevent activation of the JNK pathway induced by human oxidised low-density lipoprotein particles in pancreatic beta cells. Diabetologia. 2007 Jun;50(6):1304-14. Epub 2007 Apr 17. — View Citation
Anderson A, Campo A, Fulton E, Corwin A, Jerome WG 3rd, O'Connor MS. 7-Ketocholesterol in disease and aging. Redox Biol. 2020 Jan;29:101380. doi: 10.1016/j.redox.2019.101380. Epub 2019 Nov 14. Review. — View Citation
Benoit SR, Hora I, Albright AL, Gregg EW. New directions in incidence and prevalence of diagnosed diabetes in the USA. BMJ Open Diabetes Res Care. 2019 May 28;7(1):e000657. doi: 10.1136/bmjdrc-2019-000657. eCollection 2019. — View Citation
Birlouez-Aragon I, Saavedra G, Tessier FJ, Galinier A, Ait-Ameur L, Lacoste F, Niamba CN, Alt N, Somoza V, Lecerf JM. A diet based on high-heat-treated foods promotes risk factors for diabetes mellitus and cardiovascular diseases. Am J Clin Nutr. 2010 May;91(5):1220-6. doi: 10.3945/ajcn.2009.28737. Epub 2010 Mar 24. — View Citation
Boughton CK, Munro N, Whyte M. Targeting beta-cell preservation in the management of type 2 diabetes. British Journal of Diabetes and Vascular Disease. Published online 2017. doi:10.15277/bjd.2017.148
Butler AE, Janson J, Bonner-Weir S, Ritzel R, Rizza RA, Butler PC. Beta-cell deficit and increased beta-cell apoptosis in humans with type 2 diabetes. Diabetes. 2003 Jan;52(1):102-10. — View Citation
Chen C, Cohrs CM, Stertmann J, Bozsak R, Speier S. Human beta cell mass and function in diabetes: Recent advances in knowledge and technologies to understand disease pathogenesis. Mol Metab. 2017 Jul 8;6(9):943-957. doi: 10.1016/j.molmet.2017.06.019. eCollection 2017 Sep. Review. — View Citation
Cnop M, Hannaert JC, Grupping AY, Pipeleers DG. Low density lipoprotein can cause death of islet beta-cells by its cellular uptake and oxidative modification. Endocrinology. 2002 Sep;143(9):3449-53. — View Citation
Davis BC, Jamshed H, Peterson CM, Sabaté J, Harris RD, Koratkar R, Spence JW, Kelly JH Jr. An Intensive Lifestyle Intervention to Treat Type 2 Diabetes in the Republic of the Marshall Islands: Protocol for a Randomized Controlled Trial. Front Nutr. 2019 Jun 5;6:79. doi: 10.3389/fnut.2019.00079. eCollection 2019. — View Citation
Diabetes and African Americans, CDC 2016. Summary Health Statistics: National Health Interview Survey: 2014. US Department of Health and Human Services, Office of Minority Health website. http://www.cdc.gov/nchs/nhis/shs/tables.htm
Economic Research Service. Commodity consumption by population characteristics. United States Department of Agriculture. Published 2012. http://www.ers.usda.gov/data-products/commodity-consumption-by-population-characteristics.aspx
Endo K, Oyama T, Saiki A, Ban N, Ohira M, Koide N, Murano T, Watanabe H, Nishii M, Miura M, Sekine K, Miyashita Y, Shirai K. Determination of serum 7-ketocholesterol concentrations and their relationships with coronary multiple risks in diabetes mellitus. Diabetes Res Clin Pract. 2008 Apr;80(1):63-8. doi: 10.1016/j.diabres.2007.10.023. Epub 2008 Jan 22. — View Citation
Ferderbar S, Pereira EC, Apolinário E, Bertolami MC, Faludi A, Monte O, Calliari LE, Sales JE, Gagliardi AR, Xavier HT, Abdalla DS. Cholesterol oxides as biomarkers of oxidative stress in type 1 and type 2 diabetes mellitus. Diabetes Metab Res Rev. 2007 Jan;23(1):35-42. — View Citation
Fu D, Wu M, Zhang J, Du M, Yang S, Hammad SM, Wilson K, Chen J, Lyons TJ. Mechanisms of modified LDL-induced pericyte loss and retinal injury in diabetic retinopathy. Diabetologia. 2012 Nov;55(11):3128-40. doi: 10.1007/s00125-012-2692-0. Epub 2012 Aug 31. — View Citation
Glechner A, Keuchel L, Affengruber L, Titscher V, Sommer I, Matyas N, Wagner G, Kien C, Klerings I, Gartlehner G. Effects of lifestyle changes on adults with prediabetes: A systematic review and meta-analysis. Prim Care Diabetes. 2018 Oct;12(5):393-408. doi: 10.1016/j.pcd.2018.07.003. Epub 2018 Aug 1. — View Citation
Indaram M, Ma W, Zhao L, Fariss RN, Rodriguez IR, Wong WT. 7-Ketocholesterol increases retinal microglial migration, activation, and angiogenicity: a potential pathogenic mechanism underlying age-related macular degeneration. Sci Rep. 2015 Mar 16;5:9144. doi: 10.1038/srep09144. — View Citation
J. V. Vicente S, Sampaio G, Ferrari C, Torres E. Oxidation of Cholesterol in Foods and Its Importance for Human Health. Vol 28.; 2012. doi:10.1080/87559129.2011.594972
Kahleova H, Fleeman R, Hlozkova A, Holubkov R, Barnard ND. A plant-based diet in overweight individuals in a 16-week randomized clinical trial: metabolic benefits of plant protein. Nutr Diabetes. 2018 Nov 2;8(1):58. doi: 10.1038/s41387-018-0067-4. — View Citation
Kahleova H, Tura A, Hill M, Holubkov R, Barnard ND. A Plant-Based Dietary Intervention Improves Beta-Cell Function and Insulin Resistance in Overweight Adults: A 16-Week Randomized Clinical Trial. Nutrients. 2018 Feb 9;10(2). pii: E189. doi: 10.3390/nu10020189. — View Citation
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. — View Citation
Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6. — View Citation
Lee DH. Lipoproteins and ß-Cell Functions: From Basic to Clinical Data. Diabetes Metab J. 2014 Aug;38(4):274-7. doi: 10.4093/dmj.2014.38.4.274. — View Citation
Lin J, Thompson TJ, Cheng YJ, Zhuo X, Zhang P, Gregg E, Rolka DB. Projection of the future diabetes burden in the United States through 2060. Popul Health Metr. 2018 Jun 15;16(1):9. doi: 10.1186/s12963-018-0166-4. — View Citation
Linseisen J, Wolfram G. Absorption of cholesterol oxidation products from ordinary foodstuff in humans. Ann Nutr Metab. 1998;42(4):221-30. — View Citation
Lyons MA, Samman S, Gatto L, Brown AJ. Rapid hepatic metabolism of 7-ketocholesterol in vivo: implications for dietary oxysterols. J Lipid Res. 1999 Oct;40(10):1846-57. — View Citation
Maldonado-Pereira L, Schweiss M, Barnaba C, Medina-Meza IG. The role of cholesterol oxidation products in food toxicity. Food Chem Toxicol. 2018 Aug;118:908-939. doi: 10.1016/j.fct.2018.05.059. Epub 2018 Jun 27. Review. — View Citation
Mehta SP, Jarvis A, Standifer D, Warnimont C. International physical activity questionnaire. Critical Reviews in Physical and Rehabilitation Medicine. Published online 2018. doi:10.1615/CritRevPhysRehabilMed.2018026180
Morel DW, Lin CY. Cellular biochemistry of oxysterols derived from the diet or oxidation in vivo. Journal of Nutritional Biochemistry. Published online 1996. doi:10.1016/0955-2863(96)00101-5
Murakami H, Tamasawa N, Matsui J, Yasujima M, Suda T. Plasma oxysterols and tocopherol in patients with diabetes mellitus and hyperlipidemia. Lipids. 2000 Mar;35(3):333-8. — View Citation
Nakhjavani M, Khalilzadeh O, Khajeali L, Esteghamati A, Morteza A, Jamali A, Dadkhahipour S. Serum oxidized-LDL is associated with diabetes duration independent of maintaining optimized levels of LDL-cholesterol. Lipids. 2010 Apr;45(4):321-7. doi: 10.1007/s11745-010-3401-8. Epub 2010 Mar 12. — View Citation
Odegaard AO, Jacobs DR Jr, Sanchez OA, Goff DC Jr, Reiner AP, Gross MD. Oxidative stress, inflammation, endothelial dysfunction and incidence of type 2 diabetes. Cardiovasc Diabetol. 2016 Mar 24;15:51. doi: 10.1186/s12933-016-0369-6. — View Citation
Plaisance V, Brajkovic S, Tenenbaum M, Favre D, Ezanno H, Bonnefond A, Bonner C, Gmyr V, Kerr-Conte J, Gauthier BR, Widmann C, Waeber G, Pattou F, Froguel P, Abderrahmani A. Endoplasmic Reticulum Stress Links Oxidative Stress to Impaired Pancreatic Beta-Cell Function Caused by Human Oxidized LDL. PLoS One. 2016 Sep 16;11(9):e0163046. doi: 10.1371/journal.pone.0163046. eCollection 2016. — View Citation
Report NDS. National Diabetes Statistics Report, 2020. National Diabetes Statistics Report. Published online 2020.
RISE Consortium. Lack of Durable Improvements in ß-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes. Diabetes Care. 2019 Sep;42(9):1742-1751. doi: 10.2337/dc19-0556. Epub 2019 Jun 9. — View Citation
Rodriguez-Estrada MT, Garcia-Llatas G, Lagarda MJ. 7-Ketocholesterol as marker of cholesterol oxidation in model and food systems: when and how. Biochem Biophys Res Commun. 2014 Apr 11;446(3):792-7. doi: 10.1016/j.bbrc.2014.02.098. Epub 2014 Feb 28. Review. — View Citation
Saisho Y. An emerging new concept for the management of type 2 diabetes with a paradigm shift from the glucose-centric to beta cell-centric concept of diabetes - an Asian perspective. Expert Opin Pharmacother. 2020 Sep;21(13):1565-1578. doi: 10.1080/14656566.2020.1776262. Epub 2020 Jun 10. Review. — View Citation
Saisho Y. Importance of Beta Cell Function for the Treatment of Type 2 Diabetes. J Clin Med. 2014 Aug 14;3(3):923-43. doi: 10.3390/jcm3030923. Review. — View Citation
Samadi A, Gurlek A, Sendur SN, Karahan S, Akbiyik F, Lay I. Oxysterol species: reliable markers of oxidative stress in diabetes mellitus. J Endocrinol Invest. 2019 Jan;42(1):7-17. doi: 10.1007/s40618-018-0873-5. Epub 2018 Mar 21. — View Citation
Staimez LR, Rhee MK, Deng Y, Safo SE, Butler SM, Legvold BT, Jackson SL, Ford CN, Wilson PWF, Long Q, Phillips LS. Retinopathy develops at similar glucose levels but higher HbA(1c) levels in people with black African ancestry compared to white European ancestry: evidence for the need to individualize HbA(1c) interpretation. Diabet Med. 2020 Jun;37(6):1049-1057. doi: 10.1111/dme.14289. Epub 2020 Apr 25. — View Citation
Standl E. The importance of beta-cell management in type 2 diabetes. Int J Clin Pract Suppl. 2007 Jun;(153):10-9. Review. — View Citation
Staprans I, Pan XM, Rapp JH, Feingold KR. The role of dietary oxidized cholesterol and oxidized fatty acids in the development of atherosclerosis. Mol Nutr Food Res. 2005 Nov;49(11):1075-82. Review. — View Citation
Tonstad S, Stewart K, Oda K, Batech M, Herring RP, Fraser GE. Vegetarian diets and incidence of diabetes in the Adventist Health Study-2. Nutr Metab Cardiovasc Dis. 2013 Apr;23(4):292-9. doi: 10.1016/j.numecd.2011.07.004. Epub 2011 Oct 7. — View Citation
Wang J, Wang H. Oxidative Stress in Pancreatic Beta Cell Regeneration. Oxid Med Cell Longev. 2017;2017:1930261. doi: 10.1155/2017/1930261. Epub 2017 Aug 3. Review. — View Citation
Weigel TK, Kulas JA, Ferris HA. Oxidized cholesterol species as signaling molecules in the brain: diabetes and Alzheimer's disease. Neuronal Signal. 2019 Dec;3(4):NS20190068. doi: 10.1042/NS20190068. Epub 2019 Nov 28. Review. — View Citation
Zhyzhneuskaya SV, Al-Mrabeh A, Peters C, Barnes A, Aribisala B, Hollingsworth KG, McConnachie A, Sattar N, Lean MEJ, Taylor R. Time Course of Normalization of Functional ß-Cell Capacity in the Diabetes Remission Clinical Trial After Weight Loss in Type 2 Diabetes. Diabetes Care. 2020 Apr;43(4):813-820. doi: 10.2337/dc19-0371. Epub 2020 Feb 14. — View Citation
Zmyslowski A, Szterk A. Oxysterols as a biomarker in diseases. Clin Chim Acta. 2019 Apr;491:103-113. doi: 10.1016/j.cca.2019.01.022. Epub 2019 Jan 24. Review. — View Citation
* Note: There are 46 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Homeostasis Model Assessment of ß-cell function (HOMA-B) Index | The HOMA-B index will be calculated using the HOMA2 Calculator with fasting C-peptide and fasting blood glucose levels. This study will compare the effect of the standard American Diabetes Association (ADA) diet that contains oxysterols and a plant-based ADA diet that does not contain oxysterols on the HOMA-B index of African Americans (AAs) with prediabetes and early diabetes. | 12 Weeks | |
Primary | Glycated Hemoglobin (HbA1c) | HbA1c is a measure of glycemic control. This study will compare the effect of the standard ADA diet that contains oxysterols and a plant-based ADA diet without oxysterols on the HbA1c of AAs with HbA1c levels between 5.7% and 7.0%. | 12 weeksC-peptide levels are elevated in renal failure It is produced in equim C | |
Primary | Serum 7-Ketocholesterol (7-KC) | 7-KC is one of the most abundant oxysterols in food and serum. This study will compare the effect of a standard ADA diet with oxysterols and a plant-based ADA diet without oxysterols on serum 7-KC levels. 7-KC will be measured by tandem liquid chromatography /mass spectrometry at the Emory Lipidomics lab. | 12 weeks | |
Secondary | The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index | This index will be calculated using the HOMA2 Calculator with fasting insulin and fasting blood glucose levels. The impact of the 2 different study diets on the HOMA-IR will be determined. | 12 Weeks | |
Secondary | Fasting Insulin | Insulin is a hormone produced by beta cells in the pancreas, it regulates serum glucose levels. The impact of the 2 different study diets on fasting insulin will be determined. | 12 weeks | |
Secondary | Fasting C-Peptide | C-peptide is a short chain of amino acids that is released as a byproduct of insulin production. It is produced in equimolar amounts as endogenous insulin but excreted at a more constant rate over a longer time. It is a sensitive, clinically validated assessment of of ß-cell function. This study will measure the effect of the 2 study diets on fasting C-peptide. | 12 weeks | |
Secondary | Fasting Blood Glucose | Glucose is the main sugar found in blood. Elevated fasting blood glucose is a sign of diabetes. This study will measure the effects of the 2 study diets on fasting blood glucose. | 12 weeks | |
Secondary | Total cholesterol (TC) | TC is a measure of the total amount of cholesterol in blood. This study will determine the effect of the 2 study diets on serum TC levels. | 12 weeks | |
Secondary | High Density Lipoproteins (HDL) | HDL is the lipoprotein carrier that carries cholesterol from the cell to the liver to be excreted. This study will measure the effect of the 2 study diets on serum HDL levels. | 12 weeks | |
Secondary | Low Density Lipoproteins (LDL) | LDL is the liproprotein carrier that carries cholesterol from the liver to the cells of the body. This study will measure the effect of the 2 study diets on serum LDL levels. | 12 weeks | |
Secondary | Oxided Low Density Lipoproteins (Ox-LDL) | Ox-LDL form when LDLs carry cholesterol oxides/oxysterols. Ox-LDLs are cytotoxic and better indicators of cardiovascular risk than native LDL levels. This study will measure the effect of the 2 study diets on serum LDL levels. | 12 weeks | |
Secondary | Aspartate Amino Transferase (AST) | AST is an enzyme that is released from the liver when it is injured. It is an indicator of liver function. This study will measure the effect of the 2 study diets on AST levels. | 12 weeks | |
Secondary | Alanine Amino Transferase (ALT) | ALT is an enzyme that is released from the liver when it is injured. It is an indicator of liver function. This study will measure the effect of the 2 study diets on ALT levels. | 12 weeks | |
Secondary | Glomerular Filtration Rate (GFR) | GFR is an index of kidney function. This study will measure the effect of the 2 study diets on GFR. In addition, it is important to measure kidney function in this study because C-peptide levels are elevated in renal failure | 12 weeks | |
Secondary | Blood Urea Nitrogen (BUN) | BUN is a breakdown product of protein that is cleared from the blood by the kidneys. It is an indicator of kidney function. This study will measure the effect of the 2 study diets on BUN. | 12 weeks | |
Secondary | Creatinine | Creatinine is a by-product of normal muscle breakdown that is cleared from the blood by the kidneys. It is an indicator of kidney function. This study will measure the effect of the 2 study diets on serum creatinine levels. | 12 weeks | |
Secondary | White Blood Cell (WBC) Count | The WBC count is a measure of the number of WBCs the body. WBCs are immune cells and markers of inflammation. This study will measure the effect of the 2 study diets on WBC counts. | 12 weeks | |
Secondary | Hemoglobin (Hb) | Hb is a protein in red blood cells that carries oxygen from the lungs to the body. This study will measure the effect of the 2 study diets on Hb levels. In addition, it is important to know Hb levels because Hb abnormalities affect HbA1c levels. | 12 weeks | |
Secondary | Platelet Count | The platelet count is the number of platelets in blood. Platelets are involved in clotting, which is dysfunctional in diabetes. This study will measure the effect of the 2 study diets on platelet counts. | 12 weeks | |
Secondary | Calcium | This is measure of serum calcium levels. A plant-based diet may cause low calcium levels. This study will measure the effect of the 2 study diets on serum calcium levels. | 12 weeks | |
Secondary | Vitamin B12 | This is a measure of vitamin B-12 levels. People on plant-based diets may have lower vitamin B12 levels. This study will measure the effect of the 2 study diets on vitWBC amin B12 levels. | 12 weeks | |
Secondary | Blood pressure (BP) | BP is the pressure of circulating blood against the walls of blood vessels. It is an indicator of cardiovascular health. It will be measured at baseline, 6-weeks and post intervention. This study will measure the effect of the 2 study diets on BP. | 12 weeks | |
Secondary | Body composition using the Dual X-ray Absorptiometry (DEXA) Body Composition scan | The DEXA scan provides an analysis of body fat, muscle mass and bone density. This study will measure the effect of the 2 study diets on body composition. | 12 weeks | |
Secondary | Body Mass Index (BMI) | BMI is defined as the body weight divided by the square of the body height. This is expressed in units of kg/m². It will be used to classify study particpants according to body mass into underweight, normal, overweight or obese groups. This study will measure the effect of the 2 study diets on BMI. | 12 weeks | |
Secondary | Waist circumference (WC) | WC is the measurement taken around the abdomen at the level of the umbilicus (belly button). This measures abdominal obesity which may be a better indicator of health risk than BMI. This study will measure the effect of the 2 study diets on WC. | 12 weeks | |
Secondary | World Health Organization (WHO-5) Index of Well Being | The WHO-5 Well-Being Index is a short self-reported measure of current mental wellbeing. This study will measure the effect of the 2 study diets on this indicator of well being. | 12 weeks |
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