Type 2 Diabetes, Cardiovascular Comorbidity and Environmental Temperature

NCT04698200 | Unknown

• 1 other identifier: DiabColdHeat
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Both high and low environmental temperatures are associated worldwide with higher morbidity and mortality and an estimated 8% of the mortality is estimated to relate to non-optimum temperatures. The majority of the adverse health effects occur at to low, and not high temperatures, and already with a modest change in temperature. Persons with type 2 diabetes can be sensitive to the effect of temperature due to their altered neural, metabolic and circulatory functions. The pathophysiological responses of type 2 diabetes in a cold and hot environment are not known. The aim of the study is to examine how advanced type 2 diabetes (disease progression \>10 years) alone, an in conjunction with coronary artery diseases and hypertension affect neural, cardiovascular and metabolic responses in a cold and hot environment. Type 2 diabetes is associated with altered neural regulation, weakened cardiovascular function, structural changes in blood vessels, altered blood constitution and metabolic disturbances. These affect thermoregulation and result in increased susceptibility to cold (lesser heat production, increased heat loss) and heat (lesser sweating and heat loss). The patients are exposed under controlled conditions in a random order to both cold (+10°C) and heat (+44°C) while resting and lightly clothed for 90 min at a time. The exposure itself is preceded by baseline measurements of the parameters of interest, and followed by repeating the same measurements after the exposure. The topic of the research is very relevant due to the worldwide epidemic of type 2 diabetes. Simultaneously, the comorbid conditions associated with diabetes become more common and are related to a higher occurrence of cardiac events. The research information is useful for all individuals with type 2 diabetes in their protection and self-management of the disease, and enabling to maintain functional ability in a cold or hot environment. The research knowledge can be utilized when developing weather warning systems for the identification of susceptible populations. Health care personnel may utilize the research information while advising their patients and for proper care. An increased awareness of the health effects of both low and high temperatures improve the functional ability of individuals and reduced help reducing morbidity and mortality from weather conditions.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change of systolic and diastolic blood pressure

  Brachial, central and beat-to-beat systolic and diastolic blood pressure

  10, 20 and 30 minutes before the intervention, during the intervention in 10 minutes intervals, and 5, 10, 15, 20 25 and 30 minutes after the intervention.

Secondary Outcomes (4)

• Electrocardiogram, ECG

  3 hours

• Metabolic rate

  During the 60 minutes intervention period.

• Sweating

  During the 60 minutes intervention period and immediately after the intervention.

• Skin and body temperature

  3 hours

Study Arms (1)

Blood pressure

EXPERIMENTAL

Measurement of brachial, central and beat-to-beat blood pressure.

Other: Cold exposure

Interventions

Cold exposure OTHER

Whole body resting cold (+10 degrees centigrade) and heat (+40 degrees centigrade) for 60 minutes.

Also known as: Heat exposure

Blood pressure

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smoking
• Type 2 diabetes
• Hypertension

You may not qualify if:

• Smoking
• Chronic respiratory diseases
• Coronary artery diseases

Sponsors & Collaborators

• University of Oulu: lead
• Finnish Institute of Occupational Health: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Maastricht University: collaborator

Study Sites (1)

University of Oulu, Center for Environmental and Respiratory Health Research

Oulu, FI-90014, Finland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: January 6, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

FI (1)