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Effect of Mental Stress on Glucose Control in Patients With Diabetes Mellitus (EMSOD)

This study has been completed.
Sponsor:
Collaborator:
Kantonsspital Frauenfeld
Information provided by (Responsible Party):
Heiko Uthoff, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01396330
First received: July 12, 2011
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

Introduction Stress is part of the investigators daily life, and means to cope with it allow adaptation and survival. To this end, physiological pathways are activated, including neuroendocrine, cardiovascular and metabolic responses. In short term, the majority of consequences are beneficial, in the long run, however, chronic psychosocial stress may constitute an increased risk for coronary heart disease, type 2 diabetes, and disability.

Acute mental stress induces an exaggerated release of stress hormones e.g. catecholamine and cortisol which are thought not only to increase heart rate (HR) and blood pressure (BP) but also to increase blood glucose levels. In clinical practice, patients and health care providers are often confronted with questions concerning psychological stress as a possible reason for glucose fluctuations. Whether stress itself or poor treatment adherence is responsible for the altered glucose control remains often controversial. Differences in the inter- and intraindividual response to stress have been suggested, but only a few small studies have addressed the effect of acute psychological stress on glucose control in patients with diabetes. Patients with type 2 diabetes may overestimate the effect of acute psychological stress on glucose control but further studies are clearly needed to definitely exclude or confirm a relevant effect of stress on the glucose control in diabetic patients. For example, effects of longer lasting or repetitive events of psychological stress on glucose concentrations still remain elusive. The aim of the present study was therefore to investigate the effect of prolonged psychological stress by means of repetitive safe driving training courses on glucose control in patients with diabetes.

Patients and Methods Forty patients with type 1 or insulin-treated type 2 diabetes attending the outpatient-clinic of the Kantonsspital Frauenfeld or University Hospital of Zurich for regular visits are invited to participate. Included are patients on any oral glucose-lowering treatment and at least one daily injection of insulin, a valid driver license and written informed consent given. Exclusion criteria are diabetes duration <2 years, pregnancy, unstable coronary artery disease, limited visual acuity or unstable proliferative diabetic retinopathy, uncontrolled hypertension (BP >160/95mmHg) and pituitary or adrenal disease. The Ethics committee of the Kanton Thurgau approved the protocol and the study conform to the principles outlined in the Declaration of Helsinki.

Study protocol Each patient completes a control and a stress testing day which takes place consecutively in a randomized order. Randomization is performed by an uninvolved third person. The study is carried out at the driving training area of the Touring Club Switzerland at Hinwil. Patients are advised to have lunch before 12:00 a.m. and to abstain from food thenceforth. Drinking mineral water remains allowed during the entire study days, and the patients have to take their basal insulin and other medication as usual. Patients are advised to arrive at the driving training area between 2:30 and 3:00 p.m. At arrival, a capillary glucose measurement is carried out, and glucose concentrations ≥10mmol/l are corrected with short-acting insulin analogues (glucose target 6 - 8mmol/l). Subsequently, no additional adjustment with insulin is allowed during the study. Glucose concentrations ≤4mmol/l are always corrected with administration of 10g carbohydrate (DextroEnergy® or orange juice). On both study days, patients ingest a standard meal at 4:45 p.m. (i.e. 15min before the driving training). Immediately after the meal, short-acting insulin is injected in knowledge of the carbohydrate content (same dose on both days) or oral antidiabetics are ingested as usual. Measurements of capillary and plasma glucose concentration, blood pressure, heart rate, stress perception and salivary cortisol concentration are carried out in regular intervals between 4 and 9 p.m. on both study days.

On the control day, patients are placed in a quiet room and are permitted to read. They also have the possibility to leave the room and stay on a balcony.

On the stress testing day, patients complete a driving training with their car between 5 and 7 p.m. The driving training consists of 3 consecutive exercises: first, a slalom track on dry and wet asphalt, secondly, a full braking exercise with water obstacles. Thirdly, the car is hurled around by a mechanical plate and the patients has to regain control over it.


Condition Intervention
Diabetes Mellitus
Mental Stress
Behavioral: stress

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Prolonged Mental Stress During Safe Driving Training Courses on Glucose Control in Patients With Diabetes Mellitus Type 2

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Mean and maximum change from baseline in glucose level (mmol/l) [ Time Frame: within 240 minutes after stress ] [ Designated as safety issue: No ]
    Glucose level will be measured before and every 15-30 minutes after stress application for up to 240 minutes


Enrollment: 40
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stress Behavioral: stress
3 professional safe drive training courses each lasting 30 minutes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetes mellitus type 1 and type 2
  • stable glucose control
  • valid driver license
  • written informed consent

Exclusion Criteria:

  • pregnancy
  • unstable coronary artery disease
  • limited visual acuity or unstable proliferative diabetic retinopathy
  • uncontrolled hypertension (BP >160/95mmHg).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396330

Locations
Switzerland
Kantonsspital Frauenfeld
Frauenfeld, Switzerland, 8501
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Frauenfeld
Investigators
Principal Investigator: Peter Wiesli, MD Kantonsspital Frauenfeld
Principal Investigator: Heiko Uthoff, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Heiko Uthoff, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01396330     History of Changes
Other Study ID Numbers: EMSOD
Study First Received: July 12, 2011
Last Updated: February 28, 2012
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Diabetes Mellitus
Stress, Psychological
Behavioral Symptoms
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014