Skip to main content

Advertisement

SpringerLink
Log in

A multicentric, randomized, controlled trial of yoga and fenugreek in prevention of type 2 diabetes mellitus: methodological details—the Indian Prevention of Diabetes Study (IPDS)

  • Original Article
  • Published:
International Journal of Diabetes in Developing Countries Aims and scope Submit manuscript

Abstract

Preliminary studies have shown that yoga as well as fenugreek are beneficial in patients with type 2 diabetes mellitus (T2DM). This clinical trial is the first of its kind to prospectively evaluate in a multicentric, randomized, and controlled design if yoga and fenugreek can prevent the composite outcome of T2DM in prediabetic individuals. It aims to investigate whether there is an effective and safe treatment modality for the prevention of T2DMwhich is also-cost effective and can be implemented easily on a large scale so as to reduce the burden of T2DM. One thousand five hundred obese prediabetic individual aged 30–70 years were proposed to be identified on the basis of a 75-g oral glucose tolerance test (OGTT) and randomized to one of the three intervention arms viz standard life style measures + placebo (n = 500), standard life style measures + placebo + yoga (n = 500), and Standard life style measures + fenugreek (n = 500). Yoga consisted of a 40-min session each day which included yoga asanas and pranayamas. Fenugreek was given as fenugreek powder. All subjects were followed on an outpatient basis for 3 years, and annual OGTTs were done to pick up incident cases of diabetes mellitus. Incident rates, time to event analysis, and hazard ratios were compared between the groups. Secondary outcomes studied were change in glycemia, quality of life, cardiovascular disease and cardiovascular risk factors, beta cell function (HOMA-B), insulin resistance (HOMA-IR), and adverse events. Trial registration: Clinical trial registration number: CTRI/2013/01/003316.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Data Availability

Data available with the investigators.

References

  1. International Diabetes Federation. IDF diabetes atlas. 10th ed. Brussels, Belgium: International Diabetes Federation; 2021.

  2. Deepa M, Pradeepa R, Mahanta J, Narain K, Das HK, et al. Prevalence of diabetes and prediabetes in 15 states of India: results from the ICMR-INDIAB population-based cross-sectional study. Lancet Diabetes Endocrinol [Internet]. 2017 Aug 1 [cited 2022 Aug 7];5(8):585– 96. Available from: https://pubmed.ncbi.nlm.nih.gov/28601585/

  3. Madhu SV, Sandeep G, Mishra BK, Aslam M. High prevalence of diabetes, prediabetes and obesity among residents of East Delhi - the Delhi urban diabetes survey (DUDS). Diabetes Metab Syndr. 2018;12(6):923–7.

    Article  CAS  PubMed  Google Scholar 

  4. Pradeepa R, Mohan V. Prevalence of type 2 diabetes and its complications in India and economic costs to the nation. Eur J Clin Nutr. 2017;71:816–24.

    Article  CAS  PubMed  Google Scholar 

  5. Ramachandran A, Snehalatha C, Anil Kapur, Vijay V, Mohan V, Das AK, Rao PV. High prevalence of diabetes and impaired glucose tolerance in India-National Urban Diabetes Survey (NUDS). Diabetologia. 2001;44:1094–1101.

  6. Ramachandran A, Snehalatha C, Latha E, Vijay V, Viswanathan M. Rising prevalence of NIDDM in urban population in Indian. Diabetologia. 1997;40:232–7.

    Article  CAS  PubMed  Google Scholar 

  7. Nanditha A, Snehalatha C, Satheesh K, Susairaj P, Simon M, Vijaya L, et al. Secular TRends in DiabEtes in India (STRiDE–I): change in prevalence in 10 years among urban and rural populations in Tamil Nadu. Diabetes Care. 2019;42:476–85. https://doi.org/10.2337/dc18-1559.

    Article  PubMed  Google Scholar 

  8. Vijayakumar G, Manghat S, Vijayakumar R, Simon L, Scaria LM, Vijayakumar A, et al. Incidence of type 2 diabetes mellitus and prediabetes in Kerala, India: results from a 10-year prospective cohort. BMC Public Health. 2019;19:140.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Anjana RM, Shanthi Rani CS, Deepa M, Pradeepa R, Sudha V, Divya Nair H, et al. Incidence of diabetes and prediabetes and predictors of progression among Asian Indians:10-year follow-up of the Chennai Urban Rural Epidemiology Study (CURES). Diabetes Care. 2015;38:1441–8.

  10. Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, JiangYY, Wang JP, Zhang H, Zhang H, Bennett PH, Howard BV, Pan XR, Li GW, Hu YH, et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerence: the Da Qing IGT and Diabetes Study. Diabetes Care. 1997;20:537–544.

  11. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Hanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Aunola S, Cepaitis Z, Moltchanov, Hakumaki M, Mannelin M, Martikkala V, Sundvall J, Uusitupa M, the Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344:1343–1350.

  12. Knowler WC, Barrett-Cnnor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM, Diabetes Prevention Programme Research Group. Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346:393–403.

  13. Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V. The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian sub- jects with impaired glucose tolerance (IDPP-1). Diabetologia [Internet]. 2006 Feb [cited 2022 Sep 1];49(2):289–97. Available from: https://pubmed.ncbi.nlm.nih.gov/16391903/.

  14. Weber MB, Ranjani H, Meyers GC, Mohan V, Narayan KMV. A model of translational research for diabetes prevention in low and middle- income countries: the Diabetes Community Lifestyle Improvement Program (D-CLIP) trial. Prim Care Diabetes [Internet]. 2012 Apr [cited 2022 Sep 1];6(1):3–9. Available from: https://pubmed.ncbi.nlm.nih.gov/21616737/.

  15. Mathews E, Thomas E, Absetz P, D’Esposito F, Aziz Z, Balachandran S, et al. Cultural adaptation of a peer-led lifestyle interven- tion program for diabetes prevention in India: the Kerala diabetes preven- tion program (K-DPP). BMC Public Health [Internet]. 2018 [cited 2022 Aug 9];17(1). Available from: https://pubmed.ncbi.nlm.nih.gov/29298703/.

  16. Hostalek U, Campbell I. Metformin for diabetes prevention: update of the evidence base. Curr Med Res Opin [Internet]. 2021 [cited 2022 Aug 7];37(10):1705–17. Available from: https://pubmed.ncbi.nlm.nih.gov/34281467/.

  17. Weber MB, Ranjani H, Staimez LR, Anjana RM, Ali MK, Narayan KMV, et al. The Stepwise approach to diabetes prevention: results from the D-CLIP randomized controlled trial. Diabetes Care [Internet]. 2016 Oct 1 [cited 2022 Aug 10];39(10):1760–7. Available from: https://pubmed.ncbi.nlm.nih.gov/27504014/.

  18. Chiasson-J-L, Josse RG Gomis R, Hanefeld M, Karasik A, Laasko M, for the STOP-NIDDM Trail Research Group, Acarbose can prevent the progression of impaired glucose tolerance to type 2 diabetes mellitys: results of a randomized clinical trail: the STOP-NIDDM Trail. Lancet 2002;359:2072–7.

  19. Ipsen EØ, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020;11(11):CD013516. https://doi.org/10.1002/14651858.CD013516.pub2.

    Article  PubMed  Google Scholar 

  20. Jain Suresh C, Uppal Alka, Bhatnagar SOD, Talukdar B. A study of response pattern of non-insulin dependent diabetics to yoga therapy. Diabetes Res Clin Pract. 1993;19:69–74.

  21. Sahay BK, Murthy KHR, Raju PS, Madhavi S, Reddy MV. Long term follow studies on effect of yoga in diabetes. Diabetes Res Clin Pract. 1988;5:56.

    Google Scholar 

  22. Malhotra V, Singh S, Singh KP, Sharma SB, Madhu SV, Gupta P, Tondon OP. Effectsof yoga assanas and pranayama in non-insulin dependent diabetes mellitus. Indian J Tradit Knowl. 2004;3:162–7.

    Google Scholar 

  23. Singh S, Malhotra V, Singh KP, Sharma SB, Madhu SV, Tandon OP. A preliminary report on the role of yoga asanas on oxidative stress in non-insulin dependent diabetes. Indian J Clin Biochem. 2001;16:216–20.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Singh S, Malhotra V, Singh KP, Madhu SV, Tondon OP. Role of yoga in modifying certain cardiovascular functions in type 2 diabetic patients. J Assoc Physicians India. 2004;52:203–6.

    PubMed  Google Scholar 

  25. Malhotra V, Singh S, Tandon OP, Madhu SV, Prasad A, Sharma SB. Effect of yoga asanas on nerve conduction in type 2 diabetes. Indian J Physiol Pharmacol. 2002;46:298–306.

    PubMed  Google Scholar 

  26. Malhotra V, Singh S, Singh KP, Gupta P, Sharma SB, Madhu SV, Tandon OP. Study of yoga asanas in assessment of pulmonary function in NIDDM patients. Indian J Physiol Pharmacol. 2002;46:313–20.

    PubMed  Google Scholar 

  27. Sahay BK, Murthy KJR, Raju PS, Madhavi S, Prasad, Reddy MV, India. Role of yogic practices in prevention of non-insulin dependent diabetes mellitus (NIDDM), Special Programme presented at !5th International Diabetes Federation Congress, Kobe Japan, from November 6th – 11th ,1994: pp 95.

  28. Puri D, Prabhu KM, Murthy PS. Mechanism of action of a hypoglycemic principle isolated from fenugreek seeds. Indian J PhysiolPharmacol. 2002;46(4):457–62.

    CAS  Google Scholar 

  29. Basch E, Ulbricht C, Kuo G, Szapary P, Smith M. Therapeutic applications of fenugreek. Altern Med Rev. 2003;8(1):20–7.

    PubMed  Google Scholar 

  30. Madar Z, Stark AH. New legume sources as therapeutic agents. Br J Nutr. 2002;88(Suppl 3):S287–92.

    Article  CAS  PubMed  Google Scholar 

  31. Mohan V, Balasubramanyam M. Fenugreek and insulin resistance. J Assoc Physicians India. 2001;49:1055–6.

    CAS  PubMed  Google Scholar 

  32. Sharma RD, Raghuram TC, Rao NS. Effect of fenugreek seeds on blood glucose and serum lipids in type I diabetes. Eur J Clin Nutr. 1990;44(4):301–6.

    CAS  PubMed  Google Scholar 

  33. Bhardwaj PK, Dasgupta DJ, Prashar BS, Kaushal SS. Control of hyperglycaemia and hyperlipidaemia by plant product. J Assoc Physicians India. 1994;42(1):33–5.

    CAS  PubMed  Google Scholar 

  34. Gupta A, Gupta R, Lal B. Effect of Trigonella foenum-graecum (fenugreek) seeds on glycaemic control and insulin resistance in type 2 diabetes mellitus: a double blind placebo controlled study. J Assoc Physicians India. 2001;49:1057–61.

    CAS  PubMed  Google Scholar 

  35. Valette G, Sauvaire Y, Baccou JC, Ribes G. Hypocholesterolaemic effect of fenugreek seeds in dogs. Atherosclerosis. 1984;50(1):105–11.

    Article  CAS  PubMed  Google Scholar 

  36. Hays RD, Kallich JD, Mapes DL, Coons SJ, Canter WB. Development of kidney disease Quality of Life (KDQOL) Instrument. Qual Life Res. 1994;3:329–38.

    Article  CAS  PubMed  Google Scholar 

  37. Kutner NG. Assessing end- stage renal disease patients ‘functioning and well-being; measurement approaches and implications for clinical practice. Am J Kidney Dis. 1994;24:321–33.

    Article  CAS  PubMed  Google Scholar 

Download references

Funding

Funding for the study was provided by Research Society for the Study of Diabetes in India (RSSDI). Part of the funding was also provided by Lokumal Kishinchand Charity Trust, Mumbai. A small grant was also received from Chellaram Diabetes Institute, Pune.

Author information

Authors and Affiliations

  1. Centre for Diabetes, Endocrinology and Metabolism, University College of Medical Sciences & GTB Hospital, New Delhi, Delhi, 110095, India

    S. V. Madhu

  2. Diabetes Research Society, Hyderabad, Telangana, India

    P. V. Rao

  3. Diabetes Endocrine Nutrition Management and Research Centre, Mumbai, Maharashtra, India

    H. B. Chandalia

  4. Jothydev’s Diabetes Research Centre, Thiruvananthapuram, Kerala, India

    K. Jothydev

  5. Monilek Hospital and Research Centre, Jaipur, Rajasthan, India

    A. Gupta

Authors
  1. S. V. Madhu
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. P. V. Rao
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. H. B. Chandalia
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. K. Jothydev
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. A. Gupta
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

For Research Society for the Study of Diabetes in India

Corresponding author

Correspondence to S. V. Madhu.

Ethics declarations

Conflict of interest

The authors declare no competing interests.

Additional information

Publisher's note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Madhu, S.V., Rao, P.V., Chandalia, H.B. et al. A multicentric, randomized, controlled trial of yoga and fenugreek in prevention of type 2 diabetes mellitus: methodological details—the Indian Prevention of Diabetes Study (IPDS). Int J Diabetes Dev Ctries 43, 875–882 (2023). https://doi.org/10.1007/s13410-023-01183-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s13410-023-01183-7

Keywords

Search

Navigation