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Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes (BURST2D)

Primary Purpose

Pre-diabetes

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

BREAK

ONE

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring sedentary behavior, physical activity, glucose control, metabolism, pre-diabetes

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female
Overweight and obese BMI of 25-40 kg/m2and weight stable over the previous 6 months.
Age, 18-64 years old.
Fasting glucose of 100-125 mg/dL or fasting HbA1c of 5.7-6.4%, or 2h OGTT blood glucose of 140-199mg/dL based on the American Diabetes Association criteria for pre-diabetes.
Less than 150 minutes of moderate-to-vigorous physical activity (MVPA) per week and more than 6 hours of sitting time per day, as self-reported by the volunteers using the IPAQ.
Less than 6500 of steps per day as measured by a pedometer over 5 days (at least 1 weekend day).
Passing medical and physical screening, and analysis of blood and urine screening samples.
Low-moderate caffeine use (<3 cups/day).
Agree to refrain from any other structured exercise than the physical activity prescribed in each arm of the study.
Agree to eat control diets for 3 days before and during the CTRC visits;
Agree to refrain from taking any over-the-counter (including nonsteroidal anti-inflammatory drugs) or prescribed medication (apart from oral contraceptives) for 3 days prior to the inpatient CTRC visits;
Agree to wear a Fitbit activity monitor and upload data on the website on a daily basis for the whole duration of the study.
Agree to follow the physical activity interventions and to be randomly assigned to one of the two arms of the study.
Agree to complete all the study procedures.

Exclusion Criteria:

Pregnancy, breast-feeding or post-menopause for women.
Being considered unsafe to participate as determined by the study physician.
Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse.
History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism.
Being positive for human immunodeficiency virus or hepatitis B or C.
Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months.
Having abnormal blood chemistry and/or hematology as deemed significant by the study physician.
Being a smoker or having been a smoker in the 3 months prior to their screening visit.
Having donated over 400 mL of blood within 3 months (90 days) of screening for the study;
Working night shifts or traveling across more than 2 time zones within 1 month of and throughout the study.
Not completing the trial days of BREAK and ONE during the screening period to assess the willingness and ability of the participant to perform each of the interventions.

Sites / Locations

University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BREAK Intervention

ONE Intervention

Arm Description

Participants in the BREAK condition will perform 5-minute bouts of brisk walking hourly for 9 hours/day, 5 days/week for 3 months.

Participants in the ONE condition will perform 45 minutes of brisk walking as a single continuous bout, 5 days/week for 3 months.

Outcomes

Primary Outcome Measures

Glycemia

Plasma glucose concentration in mg/dL measured before and 30, 60, 90 and 120 min after an oral glucose tolerance test (OGTT, 75g glucose).

Secondary Outcome Measures

Insulinemia

Plasma insulin concentration in mUI/mL measured before and 30, 60, 90 and 120 min after an oral glucose tolerance test (OGTT, 75g glucose).

Mean interstitial glucose concentration

Mean interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep for 24hours for 10 days.

Daily glycemia variability

Standard deviation (SD) of interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep 24hours throughout 10 days.

Fasting A1c concentration

Fasting A1c concentration expressed in %

Fasting fructosamine concentration

Fasting fructosamine concentration in umol/L

12-hour exogenous glucose oxidation

Rates of 13C recovery (% of the dose) in expired CO2 following the ingestion of U-13C-glucose in both breakfast and lunch meals.

12-hour endogenous glucose oxidation

Rates of D2 recovery (% of the dose) in expired urines following the infusion of (2,2H2) glucose.

12 hour CO2 production

CO2 production measured by indirect calorimetry (ParvoMedics TrueOne 2400, Salt Lake City) for 20 minutes every hour from 0800h to 1800h.

12 hour O2 production

O2 production measured by indirect calorimetry (ParvoMedics TrueOne 2400, Salt Lake City) for 20 minutes every hour from 0800h to 1800h.

12 Urine excretion

Urine will be measured every hour from 0730h to 1830h

Glucose kinetics

Steele's equation for non-steady-state will be used to compute RaT and RaE, as well as the rates of disappearance (RdT and RdE) from the percentage of [6,6-2H2]glucose6 and of 13C-glucose in plasma glucose61. EGP will be computed as RaT-RaE. Nonoxidative glucose disposal (NOGD) will be calculated by subtracting total carbohydrate oxidation from (RdT + RdE). Plasma glucose utilization will be assumed to be equivalent to RdT as has been confirmed previously. Muscle glycogen utilization during the active period will be calculated as total carbohydrate utilization during exercise minus plasma glucose utilization during exercise.

Fasting and postprandial glucose

Fasting and postprandial glucose in mg/dl measured in response to standard lunch

Fasting and postprandial insulin

Fasting and postprandial insulin in ml/iu measured in response to standard lunch

Fasting and postprandial C-Peptide

Fasting and postprandial C-peptide nmol/mL measured in response to standard lunch

Fasting and postprandial glucagon

Fasting and postprandial glucagon in pg/mL measured in response to standard lunch

Fasting and postprandial catecholamines

Fasting and postprandial catecholamines in pg/mL measured in response to standard lunch

Skeletal muscle content of protein kinase B (Akt) (Aktser473/total)

Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure protein kinase B (Akt) (Aktser473/total) using western blotting.

Skeletal muscle content of ACC (ACCS79/ total)

Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure ACC (ACCS79/ total) using western blotting.

Skeletal muscle content of TBC1D4 (AS160/ total)

Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure TBC1D4 (AS160/ total) using western blotting.

Skeletal muscle content of COX4

Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure COX4 using western blotting.

Full Information

NCT ID

NCT05041491

First Posted

August 26, 2021

Last Updated

March 13, 2023

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT05041491

Brief Title

Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes

Acronym

BURST2D

Official Title

Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 30, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

October 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Newly released guidelines recommend increased physical activity (PA) and reduced sedentary behaviors (SB) to improve glycemia and prevent the onset and progression of type 2 diabetes (T2D). Typically, 30-60 min bouts of PA are advocated per day. Although this approach increases PA, it does not decrease the length of the sedentary periods through the day. This is important because recent epidemiological data suggest that frequently interrupting sedentary time improves glucose control even in people who achieve the recommended levels of PA. Preliminary experimental data suggest that breaking up prolonged sedentary time by performing multiple short bouts (5 min) of PA throughout the day, may improve glycemia more than performing a single continuous bout of PA, and thereby potentially be a novel strategy to prevent T2D. The improvement in glycemia was observed even when the total amount of PA and total energy expenditure were matched, suggesting that how and when PA is performed over the day may matter more than how much PA is done. However, important gaps in knowledge remain including: (1) whether similar benefits on glucose control would be observed in adults with prediabetes, a clinically relevant population that is at high risk of developing T2D; (2) whether these effects are sustained or diluted over time, and (3) what are the mechanistic underpinnings. To address these gaps, the investigators propose to measure the acute and chronic effects of PA breaks on glucose control and the underlying mechanisms in individuals at risk of developing T2D. Sedentary men and women with prediabetes (n=66, 50% F) will be randomized to either an intervention designed to interrupt SB with 5-min bouts of brisk walking performed hourly for 9 hours/day, 5 days/week (BREAK) or a control condition consisting of 45-min of brisk walking performed as a single daily continuous bout, 5 days/week (ONE). The two 3-months interventions will be matched for total active time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetes

Keywords

sedentary behavior, physical activity, glucose control, metabolism, pre-diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Participants will be randomized to either the BREAK condition (5-min bouts of brisk walking performed hourly for 9 hours/day, 5 days/wk) or the ONE condition (45-min of brisk walking performed as a single continuous bout, 5 days/wk) for 3 months. Participants will complete all study visits in only one group.

Masking

Outcomes Assessor

Masking Description

A study research assistant that is not involved in the study participants' allocation process will create opaque, sealed envelopes with allocation sequences based on the randomization table created by the study statistician. The assignment of intervention to study participants will be based on the study allocation sequence generated by the statistician and the study team will enroll study participants and assign them to the interventions. The study team will be blinded until study participants' allocation (the day before visit G). After this, the study team will not be blinded to study participants' allocation as they will be responsible for assigning study participants, and for applying and monitoring the interventions. The study statistician will always be blinded.

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BREAK Intervention

Arm Type

Experimental

Arm Description

Participants in the BREAK condition will perform 5-minute bouts of brisk walking hourly for 9 hours/day, 5 days/week for 3 months.

Arm Title

ONE Intervention

Arm Type

Active Comparator

Arm Description

Participants in the ONE condition will perform 45 minutes of brisk walking as a single continuous bout, 5 days/week for 3 months.

Intervention Type

Behavioral

Intervention Name(s)

BREAK

Intervention Description

The BREAK intervention is a physical activity regimen.

Intervention Type

Behavioral

Intervention Name(s)

ONE

Intervention Description

The ONE intervention is a physical activity regimen.

Primary Outcome Measure Information:

Title

Glycemia

Description

Plasma glucose concentration in mg/dL measured before and 30, 60, 90 and 120 min after an oral glucose tolerance test (OGTT, 75g glucose).

Time Frame

Glucose concentration in mg/dl, measured at fasting, during a 2 hour OGTT and after

Secondary Outcome Measure Information:

Title

Insulinemia

Description

Plasma insulin concentration in mUI/mL measured before and 30, 60, 90 and 120 min after an oral glucose tolerance test (OGTT, 75g glucose).

Time Frame

Plasma insulin concentration in mUI/mL, measured at fasting, during a 2 hour OGTT and after

Title

Mean interstitial glucose concentration

Description

Mean interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep for 24hours for 10 days.

Time Frame

Before and after 1 month and 3 months of intervention

Title

Daily glycemia variability

Description

Standard deviation (SD) of interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep 24hours throughout 10 days.

Time Frame

Before and after 1 month and 3 months of intervention

Title

Fasting A1c concentration

Description

Fasting A1c concentration expressed in %

Time Frame

Time Frame: Before and after 1 month and 3 months of intervention

Title

Fasting fructosamine concentration

Description

Fasting fructosamine concentration in umol/L

Time Frame

Before and after 1 month and 3 months of intervention

Title

12-hour exogenous glucose oxidation

Description

Rates of 13C recovery (% of the dose) in expired CO2 following the ingestion of U-13C-glucose in both breakfast and lunch meals.

Time Frame