Lifestyle Intervention in a General Population for Prevention of Ischaemic Heart Disease

Type 2 Diabetes Clinical Trial

Official title:

A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289237
• Other study ID #: RCPH - 99-1
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: October 2, 2012
• Start date: March 1999
• Est. completion date: March 2011

Study information

• Verified date: October 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results, most probably due to insufficient interventions and methodology.

Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.

After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.

The status for the project is that the four waves of intervention have been performed, the last follow-up was in March 2006.

Data collection finalized with 10 years follow-up via Central National Registries and a questionnaire. No further follow-up is scheduled for the main purposes of the study.

Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin off project are on-going.

More than 25 Ph.d. studies and more than 200 peer-review publication have so far been produced.

Summary of results, links to articles and theses at: www.Inter99.dk

Description:

In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results.

Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.

After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61301
• Est. completion date: March 2011
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• All citizens in a predefined area

Exclusion Criteria:

• Drug abuse

• Language problem

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• AMI
• CHD
• COLD
• Coronary Artery Disease
• CVD
• Diabetes Mellitus, Type 2
• Heart Diseases
• Myocardial Ischemia
• Type 2 Diabetes

Intervention

Behavioral:
• Lifestyle intervention

Locations

Country	Name	City	State
Denmark	Research Centre for Prevention and Health	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Steno Diabetes Center

Country where clinical trial is conducted

Denmark, 

References & Publications (29)

Andersen G, Wegner L, Jensen DP, Glümer C, Tarnow L, Drivsholm T, Poulsen P, Hansen SK, Nielsen EM, Ek J, Mouritzen P, Vaag A, Parving HH, Borch-Johnsen K, Jørgensen T, Hansen T, Pedersen O. PGC-1alpha Gly482Ser polymorphism associates with hypertension among Danish whites. Hypertension. 2005 Apr;45(4):565-70. Epub 2005 Feb 28. — View Citation

Andersen G, Wegner L, Yanagisawa K, Rose CS, Lin J, Glümer C, Drivsholm T, Borch-Johnsen K, Jørgensen T, Hansen T, Spiegelman BM, Pedersen O. Evidence of an association between genetic variation of the coactivator PGC-1beta and obesity. J Med Genet. 2005 May;42(5):402-7. — View Citation

Andersen KL, Echwald SM, Larsen LH, Hamid YH, Glümer C, Jørgensen T, Borch-Johnsen K, Andersen T, Sørensen TI, Hansen T, Pedersen O. Variation of the McKusick-Kaufman gene and studies of relationships with common forms of obesity. J Clin Endocrinol Metab. 2005 Jan;90(1):225-30. Epub 2004 Oct 13. — View Citation

Ek J, Rose CS, Jensen DP, Glümer C, Borch-Johnsen K, Jørgensen T, Pedersen O, Hansen T. The functional Thr130Ile and Val255Met polymorphisms of the hepatocyte nuclear factor-4alpha (HNF4A): gene associations with type 2 diabetes or altered beta-cell function among Danes. J Clin Endocrinol Metab. 2005 May;90(5):3054-9. Epub 2005 Feb 22. — View Citation

Faerch K, Lau C, Tetens I, Pedersen OB, Jørgensen T, Borch-Johnsen K, Glümer C. A statistical approach based on substitution of macronutrients provides additional information to models analyzing single dietary factors in relation to type 2 diabetes in danish adults: the Inter99 study. J Nutr. 2005 May;135(5):1177-82. Erratum in: J Nutr. 2005 Dec;135(12):2891-2. — View Citation

Glümer C, Borch-Johnsen K, Colagiuri S. Can a screening programme for diabetes be applied to another population? Diabet Med. 2005 Sep;22(9):1234-8. — View Citation

Glümer C, Carstensen B, Sandbaek A, Lauritzen T, Jørgensen T, Borch-Johnsen K; inter99 study. A Danish diabetes risk score for targeted screening: the Inter99 study. Diabetes Care. 2004 Mar;27(3):727-33. — View Citation

Glümer C, Jørgensen T, Borch-Johnsen K. Targeted screening for undiagnosed diabetes reduces the number of diagnostic tests. Inter99(8). Diabet Med. 2004 Aug;21(8):874-80. — View Citation

Glümer C, Jørgensen T, Borch-Johnsen K; Inter99 study. Prevalences of diabetes and impaired glucose regulation in a Danish population: the Inter99 study. Diabetes Care. 2003 Aug;26(8):2335-40. — View Citation

Hamid YH, Rose CS, Urhammer SA, Glümer C, Nolsøe R, Kristiansen OP, Mandrup-Poulsen T, Borch-Johnsen K, Jorgensen T, Hansen T, Pedersen O. Variations of the interleukin-6 promoter are associated with features of the metabolic syndrome in Caucasian Danes. Diabetologia. 2005 Feb;48(2):251-60. Epub 2005 Jan 11. — View Citation

Hamid YH, Urhammer SA, Glümer C, Borch-Johnsen K, Jørgensen T, Hansen T, Pedersen O. The common T60N polymorphism of the lymphotoxin-alpha gene is associated with type 2 diabetes and other phenotypes of the metabolic syndrome. Diabetologia. 2005 Mar;48(3):445-51. Epub 2005 Feb 24. — View Citation

Hamid YH, Vissing H, Holst B, Urhammer SA, Pyke C, Hansen SK, Glümer C, Borch-Johnsen K, Jørgensen T, Schwartz TW, Pedersen O, Hansen T. Studies of relationships between variation of the human G protein-coupled receptor 40 Gene and Type 2 diabetes and insulin release. Diabet Med. 2005 Jan;22(1):74-80. — View Citation

Hansen SK, Gjesing AP, Rasmussen SK, Glümer C, Urhammer SA, Andersen G, Rose CS, Drivsholm T, Torekov SK, Jensen DP, Ekstrøm CT, Borch-Johnsen K, Jørgensen T, McCarthy MI, Hansen T, Pedersen O. Large-scale studies of the HphI insulin gene variable-number-of-tandem-repeats polymorphism in relation to Type 2 diabetes mellitus and insulin release. Diabetologia. 2004 Jun;47(6):1079-87. Epub 2004 May 29. — View Citation

Hansen SK, Nielsen EM, Ek J, Andersen G, Glümer C, Carstensen B, Mouritzen P, Drivsholm T, Borch-Johnsen K, Jørgensen T, Hansen T, Pedersen O. Analysis of separate and combined effects of common variation in KCNJ11 and PPARG on risk of type 2 diabetes. J Clin Endocrinol Metab. 2005 Jun;90(6):3629-37. Epub 2005 Mar 29. — View Citation

Hansen SK, Rose CS, Glümer C, Drivsholm T, Borch-Johnsen K, Jørgensen T, Pedersen O, Hansen T. Variation near the hepatocyte nuclear factor (HNF)-4alpha gene associates with type 2 diabetes in the Danish population. Diabetologia. 2005 Mar;48(3):452-8. Epub 2005 Feb 25. — View Citation

Husemoen LL, Thomsen TF, Fenger M, Jørgensen HL, Jørgensen T. Contribution of thermolabile methylenetetrahydrofolate reductase variant to total plasma homocysteine levels in healthy men and women. Inter99 (2). Genet Epidemiol. 2003 May;24(4):322-30. — View Citation

Husemoen LL, Thomsen TF, Fenger M, Jørgensen T. Effect of lifestyle factors on plasma total homocysteine concentrations in relation to MTHFR(C677T) genotype. Inter99 (7). Eur J Clin Nutr. 2004 Aug;58(8):1142-50. — View Citation

Johansen A, Nielsen EM, Andersen G, Hamid YH, Jensen DP, Glümer C, Drivsholm T, Borch-Johnsen K, Jørgensen T, Hansen T, Pedersen O. Large-scale studies of the functional K variant of the butyrylcholinesterase gene in relation to Type 2 diabetes and insulin secretion. Diabetologia. 2004 Aug;47(8):1437-41. Epub 2004 Jul 17. — View Citation

Jørgensen ME, Glümer C, Bjerregaard P, Gyntelberg F, Jørgensen T, Borch-Johnsen K; Grennland Population Study. Obesity and central fat pattern among Greenland Inuit and a general population of Denmark (Inter99): relationship to metabolic risk factors. Int J Obes Relat Metab Disord. 2003 Dec;27(12):1507-15. — View Citation

Jørgensen T, Borch-Johnsen K, Thomsen TF, Ibsen H, Glümer C, Pisinger C. A randomized non-pharmacological intervention study for prevention of ischaemic heart disease: baseline results Inter99. Eur J Cardiovasc Prev Rehabil. 2003 Oct;10(5):377-86. — View Citation

Kessel L, Hougaard JL, Mortensen C, Jørgensen T, Lund-Andersen H, Larsen M. Visual acuity and refractive errors in a suburban Danish population: Inter99 Eye Study. Acta Ophthalmol Scand. 2004 Feb;82(1):19-24. — View Citation

Lau C, Faerch K, Glümer C, Tetens I, Pedersen O, Carstensen B, Jørgensen T, Borch-Johnsen K; Inter99 study. Dietary glycemic index, glycemic load, fiber, simple sugars, and insulin resistance: the Inter99 study. Diabetes Care. 2005 Jun;28(6):1397-403. Erratum in: Diabetes Care. 2005 Sep;28(9):2340-1. — View Citation

Nielsen EM, Hansen L, Echwald SM, Drivsholm T, Borch-Johnsen K, Ekstrøm CT, Hansen T, Pedersen O. Evidence for an association between the Leu162Val polymorphism of the PPARalpha gene and decreased fasting serum triglyceride levels in glucose tolerant subjects. Pharmacogenetics. 2003 Jul;13(7):417-23. — View Citation

Pisinger C, Vestbo J, Borch-Johnsen K, Jørgensen T. It is possible to help smokers in early motivational stages to quit. The Inter99 study. Prev Med. 2005 Mar;40(3):278-84. — View Citation

Pisinger C, Vestbo J, Borch-Johnsen K, Jørgensen T. Smoking cessation intervention in a large randomised population-based study. The Inter99 study. Prev Med. 2005 Mar;40(3):285-92. — View Citation

Pisinger C, Vestbo J, Borch-Johnsen K, Jørgensen T. Smoking reduction intervention in a large population-based study. The Inter99 study. Prev Med. 2005 Jan;40(1):112-8. — View Citation

Pisinger C, Vestbo J, Borch-Johnsen K, Thomsen T, Jørgensen T. Acceptance of the smoking cessation intervention in a large population-based study: the Inter99 study. Scand J Public Health. 2005;33(2):138-45. — View Citation

Rose CS, Andersen G, Hamid YH, Glümer C, Drivsholm T, Borch-Johnsen K, Jørgensen T, Pedersen O, Hansen T. Studies of relationships between the GLUT10 Ala206Thr polymorphism and impaired insulin secretion. Diabet Med. 2005 Jul;22(7):946-9. — View Citation

Torekov SS, Larsen LH, Glümer C, Borch-Johnsen K, Jørgensen T, Holst JJ, Madsen OD, Hansen T, Pedersen O. Evidence of an association between the Arg72 allele of the peptide YY and increased risk of type 2 diabetes. Diabetes. 2005 Jul;54(7):2261-5. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CHD and other lifestyle related diseases after ten years	Ongoing analyses in National Central Registers (Oct 2012)	2012	No
Secondary	Changes in lifestyle and biological markers after one, three and five years	Analyses completed. Results at: www.Inter99.dk	2006	No

External Links

•   Study description and results. All publications available. Also in English.