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Breaking up sedentary time to improve glucose control in a population at risk for developing type 2 diabetes

Study category: Diabetes & Hormone Disorders

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Description

This randomized control trial examines differences in glycemia and insulin sensitivity, acute and 1-month glucose fluctuations and 1-month glucose disposal pathways between two physical activity strategies: BREAK and ONE. The BREAK strategy consists of 5-minute bouts of brisk walking performed hourly for 9 hours/day, 5 days per week, and the ONE strategy consists of a single 45-minute bout of brisk walking 5 days per week. The intervention will be maintained for two more months and glucose control will be tested. Participants will be male and female adult volunteers with overweight or obesity and pre-diabetes, a population that may be seeking physical activity options to control glucose.

Details
Age

Adult

Eligibility

- Male and female - Overweight and obese BMI of 25-40 kg/m2and weight stable over the previous 6 months. - Age, 18-45 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.

Inclusion Criteria: -Male and female - Overweight and obese BMI of 25-40 kg/m2and weight stable over the previous 6 months. - Age, 18-45 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 alcohol and caffeine for 72 h before and during the inpatient CTRC visits. - 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 (Dr. Bessesen). - 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. - Having a positive drugs of abuse urine screen at screening or upon entry into the laboratory session. - 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.

Type of Study

Outcomes Research

Scope

Local

Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Audrey Bergouignan,  PhD

Audrey Bergouignan, PhD

Study ID

Protocol Number: 20-1900

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