Skip to content

Improving glucose monitoring with lifestyle intervention for individuals with impaired glucose tolerance

Determining precision of continuous glucose monitors for quantifying 24 h glycemia in response to dietary modification and exercise in men with impaired glucose tolerance.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000742673
Enrollment
16
Registered
2014-07-14
Start date
2014-09-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study aims to establish the validity and precision of continuous glucose monitors (CGM's) for determining glycemia in response to diet and exercise. CGM's are a new, minimally invasive technology that provide greater insight into the direction, magnitude and frequency of daily glucose fluctuations. Postprandial glycemia is a significant determinant of glycemic control in individuals with impaired glucose tolerance. Given the prevalence of diabetes, it is important to identify effective lifestyle interventions to treat and manage pre-diabetes, and quantify the capacity to monitor daily variations in glucose control. We hypothesise that CGM precision will be reduced during high glucose excursions and strenuous exercise, and that high intensity exercise will be superior for promoting the return of glycemia to basal levels.

Interventions

This study will utilise a within subject (cross-over) design and each 3 day intervention period will be separated by a minimum one week washout period. Each participant will undertake four separate experimental trials: (1) a series of low glycemic index (GI) meals (2) a series of high glycemic meals (3) low intensity intermittent training (LIT) and (4) high intensity interval training (HIT). A description of the dietary and exercise interventions are provided below. Continuous glucose monitor:

This study will utilise a within subject (cross-over) design and each 3 day intervention period will be separated by a minimum one week washout period. Each participant will undertake four separate experimental trials: (1) a series of low glycemic index (GI) meals (2) a series of high glycemic meals (3) low intensity intermittent training (LIT) and (4) high intensity interval training (HIT). A description of the dietary and exercise interventions are provided below. Continuous glucose monitor: The glucose sensor (Medtronic EnliteTM) will be inserted on the side of the torso under the skin 24 h prior to each experimental trial. The device will remain in situ for 72 hours and is water proof and does not prevent bathing or swimming activities. This will be repeated for each of the four experimental trials. Insertion of the microdialysis fibre into the superficial subcutaneous adipose tissue does not require anaesthetic, is minimally invasive and barely discernible. The glucose sensor measures interstitial glucose concentration and is connected to the digital recorder (Medtronic iProTM2). They are both secured to the skin surface by medical adhesive dressing (3MTM Tegaderm) and require no further intervention until removed. Dietary Intervention: All meals and snacks will be provided during each 12 h experimental trial. The low and high GI diets will be matched for carbohydrate (60%), protein (10-15%) and fat (25-30%) content but will differ in the glycemic index. The glycemic index of breakfast, lunch and dinner of the low and high GI diet will differ by ~40, 40 and 10 U, respectively. Breakfast, lunch and dinner will each be separated by 5 h and consumed at ~0730, 1230 and 1730 h during each experimental trial. Exercise Intervention: All meals and snacks from the high GI diet trial will be provided during each exercise trial. The two exercise sessions will be performed on separate occasions and will be matched for total mechanical work but will differ in the exercise intensity and duration. The LIT protocol will involve 3 x 15 minute bouts of cycling performed at 40% peak power output (PPO). One 15 minute bout of exercise will be undertaken prior to each meal (5 h recovery period between exercise bouts). The HIT protocol will involve a 5 minute warm up and 12 × 60 s repetitions of cycling at 80% PPO, each interspersed with 60 s active recovery at 40% PPO. The single HIT session will be undertaken before the first meal (breakfast) during the experimental trial. All exercise will be performed on a stationary indoor cycle ergometer. Heart rate (HR) and rating of perceived exertion (RPE) will be measured during exercise. Blood samples will be taken at rest prior to commencing the experimental trial, and at regular intervals throughout the day. Blood will be extracted via a catheter placed into a forearm vein.

Sponsors

Stephanie Zietek
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
20 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

Fasting plasma glucose value between 5.6-6.9 mmol/L HbA1c value between 5.7-6.4% Physically inactive (< 30 minutes of physical activity per week) Body mass index < 29.9 kg/m2

Exclusion criteria

Obesity (BMI > 30kg/m2) Uncontrolled hypertension (> 160 mmHg systolic and/or > 100 mmHg diastolic) History of cardiovascular disease Liver disease Contraindications to exercise training

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026