Twenty-year Follow-up of the Inter99 Cohort

NCT05166447 | Enrolling By Invitation

• 1 other identifier: INTER99 twenty year follow-up
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

Being born small increases your risk of developing Type 2 diabetes (T2D) with age. Furthermore, data even suggest that some of the diseases ("complications") in the eyes, kidneys, nerves, liver, blood vessels and heart often seen in T2D patients may not only be due to high blood sugar levels, but rather they to some extent are due to reduced growth in your mother´s womb. The Inter99 cohort included 6784 Danish citizens aged 30 to 60 years when established 20 years ago. Data from the Inter99 cohort showed a strong role of low birth weight (LBW) on T2D risk. The aim is now to reexamine risk of T2D and complications in all the alive 6004 elderly Inter99 participants. Importantly, today there are available techniques to perform detailed examinations for even the earliest signs of complications in both subjects with and without diabetes, and the results of this study will altogether provide important new insights into both the origin and classification of T2D and associated complications. It is hypothesized that being born with lower birth weights increases the adult risk of T2D and heart disease and associated complications in the large and smaller blood vessels.

Conditions

Coronary Heart Disease; Acute Myocardial Infarction; Cardiovascular Diseases; Type 2 Diabetes; Obesity; Birth Weight

Keywords

type 2 diabetes; cardiovascular disease; fetal programming; birth weight; developmental origins of health and disease; obesity

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE) (Register data)

  Composite endpoint of cardiovascular mortality, nonfatal myocardial infarction and nonfatal stroke (3 points MACE). Data are retrieved from the Danish national registers as described in the "study population" section.

  As data are collected from registers, the events are registered as they occur up until 1 Jan 2020.

Secondary Outcomes (15)

• Type 2 diabetes incidence (register data)

  As data are collected from registers, the events are registered as they occur up until 1 Jan 2020.

• Diabetic retinopathy (Optos)

  Measured one time during the clinical follow-up study (Day 1).

• Liver stiffness (FibroScan)

  Measured one time during the clinical follow-up study (Day 1).

• Heart rate variability (Vagus device)

  Assessed in each participant at the clinical follow-up (Day 1).

• Pulse wave velocity (SphygmoCor)

  Assessed in each participant at the clinical follow-up (Day 1).

Eligibility Criteria

• Age: 50 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Former participants of the Inter99 cohort, now aged 50-80 years, will be re-invited to participate in the Inter99-20-year follow-up study. A search of the Danish nationwide civil register (CPR register) in December 2019 showed that 6,004 (88.5%) participants reside in Denmark are currently alive. Based on our experience, we expect that at least 4,000 incl. 500 or more T2D patients will participate in the follow-up study. All participants are invited to a follow-up health examination in CCRP located in Glostrup.

You may qualify if:

• Have participated in the Inter99 Baseline examination.

You may not qualify if:

• Physically or cognitively unable to participate in the 3-hour clinical follow-up study.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Steno Diabetes Center Copenhagen: collaborator
• The Novo Nordisk Foundation Center for Basic Metabolic Research: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Center for Klinisk Forskning og Forebyggelse

Glostrup Municipality, 2600, Denmark

Location

Related Publications (44)

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• Pilgaard K, Faerch K, Poulsen P, Larsen C, Andersson EA, Pisinger C, Toft U, Aadahl M, Pedersen O, Hansen T, Borch-Johnsen K, Vaag A, Jorgensen T. Impact of size at birth and prematurity on adult anthropometry in 4744 middle-aged Danes - The Inter99 study. J Dev Orig Health Dis. 2010 Oct;1(5):319-28. doi: 10.1017/S2040174410000413.

  PMID: 25141935 RESULT

• Pilgaard K, Faerch K, Carstensen B, Poulsen P, Pisinger C, Pedersen O, Witte DR, Hansen T, Jorgensen T, Vaag A. Low birthweight and premature birth are both associated with type 2 diabetes in a random sample of middle-aged Danes. Diabetologia. 2010 Dec;53(12):2526-30. doi: 10.1007/s00125-010-1917-3. Epub 2010 Sep 22.

  PMID: 20859612 RESULT

• Munch IC, Larsen M, Kessel L, Borch-Johnsen K, Lund-Andersen H, Glumer C. Cumulative glycemia and microangiopathy in subjects with impaired glucose regulation in the Inter99 study. Diabetes Res Clin Pract. 2011 Feb;91(2):226-32. doi: 10.1016/j.diabres.2010.10.017. Epub 2010 Dec 3.

  PMID: 21130512 RESULT

• Engberg S, Vistisen D, Lau C, Glumer C, Jorgensen T, Pedersen O, Borch-Johnsen K. Progression to impaired glucose regulation and diabetes in the population-based Inter99 study. Diabetes Care. 2009 Apr;32(4):606-11. doi: 10.2337/dc08-1869. Epub 2008 Dec 29.

  PMID: 19114617 RESULT

• Bjornsbo KS, Brons C, Aadahl M, Kampmann FB, Friis Bryde Nielsen C, Lundbergh B, Wibaek R, Karhus LL, Madsen AL, Hansen CS, Norgaard K, Jorgensen NR, Suetta C, Kjaer M, Grarup N, Kanters J, Larsen M, Kober L, Kofoed KF, Loos R, Hansen T, Linneberg A, Vaag A. Protocol for the combined cardiometabolic deep phenotyping and registry-based 20-year follow-up study of the Inter99 cohort. BMJ Open. 2024 Jan 29;14(1):e078501. doi: 10.1136/bmjopen-2023-078501.

  PMID: 38286704 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine used in this project will be analyzed immediately and then destroyed. Participants will be asked for permission to store blood and urine in a biobank for future unspecified research that is not part of current project. The biological material will be stored in a biobank at the Center for Clinical Research and Prevention, Rigshospitalet, Glostrup, Denmark and/or at Steno Diabetes Center Copenhagen, Gentofte, Denmark. If participants grant permission, the material will be stored for 50 years or as long as national law allows. Biological material can only be used in a new research project with permission from the Regional Committee on Health Research Ethics Denmark for the Capital Region.

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Obesity; Birth Weight; Developmental Origins of Health and Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prenatal Exposure Delayed Effects; Prenatal Injuries; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Allan A Vaag, D.M.Sc/D.Sc

  Steno Diabetes Center Copenhagen, The Capital Region of Denmark

  PRINCIPAL INVESTIGATOR

• Allan Linneberg, PhD

  Center for Clinical Research and Prevention, The Capital Region of Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Professor, MD, PhD

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: December 22, 2021
• Study Start: September 13, 2021
• Primary Completion: September 1, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

DK (1)