Study of 24 Hour Blood Pressure and the Association to Complications to Type 1 Diabetes

NCT01171248 | Completed

• 1 other identifier: PROFIL-H-B-2009-056
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP) in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation between central and peripheral 24 hour BP and a possible association to late complications in diabetes.

Conditions

Type 1 Diabetes; Hypertension

Keywords

nocturnal blood pressure dip; complications; ambulatory blood pressure

Outcome Measures

Primary Outcomes (1)

• Ambulatory blood pressure (AMBP)

  The participants are seen once (cross-sectional) and we measure AMBP in order for us to investigate any association between AMBP and other parameters such as age, duration of diabetes, albuminuria status and other diabetic complications.

  2 years

Secondary Outcomes (1)

• Diabetic late complications

  2 years

Study Arms (2)

type 1 diabetes

non-diabetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

type 1 diabetic patients (600 patients) non-diabetic controls (50)

You may qualify if:

• Type 1 diabetes
• more than 18 years of age

You may not qualify if:

• End Stage Renal Disease (ESRD)
• dialysis
• other kidney disease than diabetic nephropathy

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Related Publications (3)

• Hansen CS, Rasmussen DGK, Hansen TW, Nielsen SH, Theilade S, Karsdal MA, Genovese F, Rossing P. Collagen turnover is associated with cardiovascular autonomic and peripheral neuropathy in type 1 diabetes: novel pathophysiological mechanism? Cardiovasc Diabetol. 2023 Jun 29;22(1):158. doi: 10.1186/s12933-023-01891-8.

  PMID: 37386485 DERIVED

• Theilade S, Lajer M, Hansen TW, Rossing P. Pulse wave reflection is associated with diabetes duration, albuminuria and cardiovascular disease in type 1 diabetes. Acta Diabetol. 2014 Dec;51(6):973-80. doi: 10.1007/s00592-014-0651-6. Epub 2014 Oct 2.

  PMID: 25274394 DERIVED

• Theilade S, Lajer M, Hansen TW, Joergensen C, Persson F, Andresdottir G, Reinhard H, Nielsen SE, Lacy P, Williams B, Rossing P. 24-hour central aortic systolic pressure and 24-hour central pulse pressure are related to diabetic complications in type 1 diabetes - a cross-sectional study. Cardiovasc Diabetol. 2013 Aug 27;12:122. doi: 10.1186/1475-2840-12-122.

  PMID: 23978271 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Rossing, MD, DmSc

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician, DMSc

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 22, 2011

Record last verified: 2011-09

Locations

DK (1)