Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of Interrupting Sedentary Time in Management of Type-2 Diabetes (Just_StandUp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738996
Recruitment Status : Unknown
Verified March 2016 by Glasgow Caledonian University.
Recruitment status was:  Not yet recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
University of Strathclyde
Information provided by (Responsible Party):
Glasgow Caledonian University

Brief Summary:

Type-2 diabetes, a common non-infectious disease, is the result of impaired insulin function and insulin production in the body. In type-2 diabetic patients, postprandial glucose control, lipid control and reduction of insulin resistance are crucial to deter the development of diabetes related complications (e.g. retinopathy, nephropathy, neuropathy and cardiovascular diseases), pancreatic β cells failure, morbidity and mortality. Currently, diet, exercise and standard oral medicines are used to treat type-2 diabetes. However, providing the most effective treatment to control postprandial glucose and lipid; and to preserve the pancreatic β cells is challenging because poor metabolic profiles are still detected in type-2 diabetic patients. Therefore, understanding the factors influencing the poor metabolic profiles and adjunct therapy to manage type-2 diabetes are really important to tackle this disease.

In modern society, people are spending most of their waking time in sedentary behaviour, which is primarily prolonged sitting. Prolonged sedentary time is associated with increased postprandial glucose, lipid and insulin resistance. In contrast, frequent interruption of prolonged sitting with short light activity break reduces postprandial glucose, triglyceride cholesterol and insulin resistance. However, how frequently patients should interrupt sitting, potential longer-term effect of short activity break on reduction of postprandial glucose, triglyceride cholesterol and insulin resistance, and the knowledge, beliefs and experiences on the use of technology to decrease sedentary behaviour and improve glycaemic control are not investigated in type-2 diabetic patients. Therefore, it would be relevant to investigate this to prove the therapeutic role of frequent short activity break in sedentary time in the management of type-2 diabetes.

Primary Research Objective:

  1. To investigate the dose-response effect of frequency/number of light intensity walking breaks of sitting on postprandial glucose, insulin, C-peptide and triglyceride cholesterol level.
  2. To investigate the potential longer-term effect of light intensity walking breaks of sitting on glucose control using 24-h glucose data.

Secondary Research Objectives: The secondary objectives are

  1. To obtain data to inform the development of a future feasibility trial investigating the feasibility, compliance, adherence and longer-term effect of different frequencies of light intensity walking breaks in sitting time on glycaemic excursions in free-living.
  2. To explore the knowledge, beliefs and experiences of those with Type 2 diabetes on the use of technology to decrease sedentary behaviour and improve glycaemic control, that could be used in the feasibility trial

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Sedentary time breaks either every 60 minutes Behavioral: Sedentary time breaks either every 30 minutes Behavioral: Sedentary time breaks every 15 minutes Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Response of Glycaemic Excursions in Type-2 Diabetes to Interrupting Prolonged Sedentary Behaviour (Sitting)
Study Start Date : May 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 60-30 min
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min and 30 min
Behavioral: Sedentary time breaks either every 60 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every

Behavioral: Sedentary time breaks either every 30 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min

Experimental: 30-15 min
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min and 15 min
Behavioral: Sedentary time breaks either every 30 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min

Behavioral: Sedentary time breaks every 15 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every 15 minutes

Experimental: 15-60 min
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min and 60 min
Behavioral: Sedentary time breaks either every 60 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every

Behavioral: Sedentary time breaks every 15 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every 15 minutes

Experimental: 60-15
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min and 15 min
Behavioral: Sedentary time breaks either every 60 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every

Behavioral: Sedentary time breaks every 15 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every 15 minutes

Experimental: 30-60 min
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min and 60 min
Behavioral: Sedentary time breaks either every 60 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every

Behavioral: Sedentary time breaks either every 30 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min

Experimental: 15-30 min
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min and 30 min
Behavioral: Sedentary time breaks either every 30 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min

Behavioral: Sedentary time breaks every 15 minutes
Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min
Other Name: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every 15 minutes




Primary Outcome Measures :
  1. Postprandial glucose excursions measured with Area under curve [ Time Frame: 8 hours ]
    Dose-response relationship between frequencies of short light activity breaks in sedentary time and postprandial glucose excursions


Secondary Outcome Measures :
  1. 24 hours glucose profile measured with continuous glucose monitor LifeStyle Libre [ Time Frame: 24 hours ]
    The effect of interruption of sedentary time with frequent short activity break on 24 hr glucose profile, insulin, C-peptide and triglyceride cholesterol levels will be assessed during each intervention. Then knowledge, beliefs and experiences of the type-2 diabetic patients on the use of technology to decrease sedentary behaviour and improve glycaemic control will be assessed.

  2. Insulin, C-peptide and triglyceride cholesterol plasma level during the intervention measured with Area under curve [ Time Frame: 8 hours ]
    The effect of interruption of sedentary time with frequent short activity break on 24 hr glucose profile, insulin, C-peptide and triglyceride cholesterol levels will be assessed during each intervention. Then knowledge, beliefs and experiences of the type-2 diabetic patients on the use of technology to decrease sedentary behaviour and improve glycaemic control will be assessed.

  3. Qualitative exploration of the knowledge, beliefs and experiences of those with type 2 diabetes on the use of technology to decrease sedentary behaviour and improve glycaemic control [ Time Frame: 1 hour ]
    The effect of interruption of sedentary time with frequent short activity break on 24 hr glucose profile, insulin, C-peptide and triglyceride cholesterol levels will be assessed during each intervention. Then knowledge, beliefs and experiences of the type-2 diabetic patients on the use of technology to decrease sedentary behaviour and improve glycaemic control will be assessed.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with type 2 diabetes for less than 10 years
  • Individuals aged 35-60 years
  • Individuals receiving metformin or diet control
  • Non-smokers
  • Overweight and obese individuals (BMI 25-35 kg/m2)
  • Individuals with an HbA1c between >7%
  • Individuals with BP below 160/90mmHg

Exclusion Criteria:

  • Individuals unable or unwilling to consent
  • Individuals under the age of 35 years and over the age of 60 years at study enrolment
  • Patients on sulphonylurea or other oral hypoglycaemic drugs therapy except metformin
  • Individuals with hepatic or renal dysfunction
  • Individuals with body mass index greater than 35
  • Individuals suffering from cancer, cardiovascular diseases, cirrhosis, hepatitis and renal disease
  • Pregnant Individuals
  • Individuals who smoke
  • Individuals who are alcohol and drug abusers
  • Individuals with a blood pressure ≥160/90mmHg
  • Individuals diagnosed with anaemia (Hb<12g/dl in women and <13 g/dl in men)
  • Individuals taking medicines which can interfere with the glucose metabolism (e.g. anticoagulants, oral contraceptives, steroid, thiazide, β-blocker, NSAID, anti-fungal, hormonal therapy, psychotropic drugs)
  • Individual taking drugs for glycaemic control in excess of standard care highlighted by the SIGN guideline 116.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738996


Contacts
Layout table for location contacts
Contact: Sebastian Chastin, PhD 441413313744 Sebastien.Chastin@gcu.ac.uk
Contact: Aye Paing, MBBS 441413313357 ayechan.paing@gcu.ac.uk

Sponsors and Collaborators
Glasgow Caledonian University
University of Strathclyde
Investigators
Layout table for investigator information
Principal Investigator: Andrew Collier, , MBchb Glasgow Caledonian University

Publications:
Dempsey, P.C., Owen, N., Larsen, R., Straznicky, N., Cohen, Neale., FACSM, B.B., Kingwell, B.A., Dunstan, D.W., Baker IDI Heart and Diabetes Institute, Melbourne, Australia., Department of Health and Exercise Science, Colorado State University, Fort Collins, Colorado, USA. 2015. Interrupting Prolonged Sitting: A Potential Therapeutic Tool in the Management of Type 2 Diabetes

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT02738996     History of Changes
Other Study ID Numbers: Just_StandUp
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Glasgow Caledonian University:
Diabetes
Sedentary Lifestyle
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases