Personalised advice for breaking up prolonged sitting in people with type 2 diabetes

bREaking up prolonged Sitting in People with type 2 diabetes: Optimising the respoNSE (RESPONSE) - a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63494266

Enrollment

Registered

2021-01-14

Start date

2020-01-11

Completion date

Unknown

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving glucose control in people with type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

This study consists of two distinct parts. Part 1 is a lab-based study and Part 2 is a 4-week intervention. This study has 2 randomisation elements. To determine the order of assessment activities dur

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women 2. Age 40 to 75 years, inclusive 3. Diagnosed T2DM with 5 years 4. Diabetes controlled by diet alone, or receiving mono- or dual-therapy 5. HbA1c levels =9% 6. Able and willing to give informed consent 7. Able to understand spoken and written English 8. Able to undertake light physical activity 9. Weight stable; = 3kg weight change in the preceding 3 months 10. Willingness and availability to participate in the proposed intervention

Exclusion criteria

Exclusion criteria: 1. Type 1, gestational, or monogenic diabetes mellitus 2. On insulin therapy 3. Changes to glucose-lowering medication regime within the preceding 3 months 4. Hospital admission in the preceding 3 months 5. Current or planned pregnancy or breastfeeding 6. Contra-indications to exercise 7. Participation in another research study with investigational medical product in the preceding 3 months 8. Currently participating in a structured exercise programme 9. Serious illness with life expectancy < 1 year 10. Individuals with a history of chronic pancreatitis 11. Previous major amputation 12. Recent cardiovascular event (within 12 months) 13. Steroid use 14. Comorbidity that the research team consider to be a contraindication to involvement in the study 15. Unable to communicate in English 16. Unable to provide written informed consent 17. Diabetic foot ulcers, gangrene 18. Recent diagnosis or treatment for cancer (within 12 months)

Design outcomes

Primary

Measure	Time frame
Part 1 – Lab-based 1. Affective responses to different activities used to break prolonged sitting time measured using the feelings scale during the second lab visit after each activity break in the 5.5 h sitting period at 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, and 320 min Part 2 – Intervention 1. Postprandial glucose excursions measured using a continuous glucose monitoring system worn in free-living conditions where measurements are taken continuously for an 8 day period at baseline and 4 weeks	—

Measure

Time frame

Part 1 – Lab-based 1. Affective responses to different activities used to break prolonged sitting time measured using the feelings scale during the second lab visit after each activity break in the 5.5 h sitting period at 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, and 320 min Part 2 – Intervention 1. Postprandial glucose excursions measured using a continuous glucose monitoring system worn in free-living conditions where measurements are taken continuously for an 8 day period at baseline and 4 weeks

—

Secondary

Measure	Time frame
Part 1 – Lab-based 1. Relative intensity of each activity used for breaking up sitting time measured using the BORG rate of perceived exertion during the second lab visit after each activity break in the 5.5 h sitting period at 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, and 320 min 2. Energy expenditure of different activities used for breaking up prolonged sitting time measured through expired gas analysis during the second lab visit after each activity break in the 5.5 h sitting period at 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, and 320 min 3. Degree of muscle activation of different activities used for breaking up prolonged sitting time measured through electromyography during the second lab visit after each activity break in the 5.5 h sitting period at 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, and 320 min Part 2 – Intervention 1. Glucose variability (% and standard deviation), average blood glucose, time in range, time above range, time below range, high blood glucose index, low blood glucose index, number of hyperglycaemic episodes, and number of hypoglycaemic episodes measured using a continuous glucose monitoring system worn in free-living conditions where measurements are taken continuously for an 8 day period at baseline and 4 weeks 2. Area under the curve for postprandial glucose, insulin, triglycerides derived from the mixed meal challenge at baseline and 4 weeks 3. Fasting glucose, insulin, triglycerides, and full lipid profile are measured through a fasted blood sample at baseline and 4 weeks 4. Physical function is measured using the Hand Grip Strength (HGS) test, Short Physical Performance Battery (SPPB), modified Physical Performance Test (mPPT), and incremental shuttle walk test (ISWT) at baseline and 4 weeks 5. Adherence	—

Measure

Time frame

Part 1 – Lab-based 1. Relative intensity of each activity used for breaking up sitting time measured using the BORG rate of perceived exertion during the second lab visit after each activity break in the 5.5 h sitting period at 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, and 320 min 2. Energy expenditure of different activities used for breaking up prolonged sitting time measured through expired gas analysis during the second lab visit after each activity break in the 5.5 h sitting period at 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, and 320 min 3. Degree of muscle activation of different activities used for breaking up prolonged sitting time measured through electromyography during the second lab visit after each activity break in the 5.5 h sitting period at 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, and 320 min Part 2 – Intervention 1. Glucose variability (% and standard deviation), average blood glucose, time in range, time above range, time below range, high blood glucose index, low blood glucose index, number of hyperglycaemic episodes, and number of hypoglycaemic episodes measured using a continuous glucose monitoring system worn in free-living conditions where measurements are taken continuously for an 8 day period at baseline and 4 weeks 2. Area under the curve for postprandial glucose, insulin, triglycerides derived from the mixed meal challenge at baseline and 4 weeks 3. Fasting glucose, insulin, triglycerides, and full lipid profile are measured through a fasted blood sample at baseline and 4 weeks 4. Physical function is measured using the Hand Grip Strength (HGS) test, Short Physical Performance Battery (SPPB), modified Physical Performance Test (mPPT), and incremental shuttle walk test (ISWT) at baseline and 4 weeks 5. Adherence

—

Countries

England, United Kingdom

Contacts

Public ContactTom Yates

ty20@leicester.ac.uk+44 (0)116 258 4312

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026