NCT00442884

Brief Summary

The study is designed to evaluate the effects of acute psychological stress on blood glucose levels. We will study one group of patients in the fasting state on a control day and a stress test day, another group will undergo the same protocol in the postprandial state.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2006

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
Last Updated

March 5, 2007

Status Verified

March 1, 2007

First QC Date

March 2, 2007

Last Update Submit

March 2, 2007

Conditions

Type 2 Diabetes

Keywords

glucose control in acute stress

Outcome Measures

Primary Outcomes (1)

  • change of glucose measurements after stress test in the fasting and fed state

Interventions

Trier Social Stress Test (TSST)BEHAVIORAL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • oral antidiabetic treatment and/or long acting insulin overnight

You may not qualify if:

  • full insulin regimen
  • pregnancy or breast-feeding
  • instable coronary heart disease
  • poor visibility
  • proliferative diabetic retinopathy
  • uncontrolled arterial hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich, Division of Endocrinology and Diabetes

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Faulenbach M, Uthoff H, Schwegler K, Spinas GA, Schmid C, Wiesli P. Effect of psychological stress on glucose control in patients with Type 2 diabetes. Diabet Med. 2012 Jan;29(1):128-31. doi: 10.1111/j.1464-5491.2011.03431.x.

    PMID: 21883440DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Peter Wiesli, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 5, 2007

Study Start

February 1, 2006

Study Completion

August 1, 2006

Last Updated

March 5, 2007

Record last verified: 2007-03

Locations

CH(1)