Continuous Glucose Monitoring During a Mediterranean Diet With Sequential Cycling and Rowing in Women With Prediabetes or Recent Remission From Prediabetes: a Prospective Non-randomised Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Fasting Plasma Glucose (FPG)
研究概览
简要总结
The goal of this clinical trial is to learn how a Mediterranean-style diet, with and without added exercise, affects blood sugar control in women with prediabetes. Prediabetes means blood sugar levels are higher than normal but not yet type 2 diabetes. Healthy eating and regular physical activity can help prevent diabetes.
The investigators aim to answer two main questions:
- Does adding a supervised program of cycling and rowing exercises to the diet lead to better blood sugar control than the diet alone?
- Do women who recently returned to normal blood sugar levels respond differently to the exercise program than those who currently have high blood sugar?
Participants will be placed into one of three groups based on current blood sugar levels and medical fitness for exercise:
- Group 1 (Diet only): Will follow a Mediterranean eating plan for 12 weeks.
- Group 2 (Diet + Exercise, Current High Blood Sugar): Will follow the same diet and also do supervised exercise (cycling, then rowing) three times a week for 8 weeks.
- Group 3 (Diet + Exercise, Recent Normal Blood Sugar): Will follow the same diet and exercise program as Group 2. These women had prediabetes in the past year but now have normal blood sugar levels.
All participants will follow the study protocol for 12 weeks, which includes the following key components:
- Dietary Intervention: Adherence to a Mediterranean-style eating plan, which emphasizes high intake of vegetables, fruits, whole grains, legumes, olive oil, and fish.
- Continuous Glucose Monitoring: Wearing a continuous glucose monitoring (CGM) device-a small, minimally invasive sensor placed on the upper arm-during multiple 10-day periods. This device tracks interstitial glucose levels throughout the day and night to assess daily glucose patterns.
- Blood Sampling and Analysis: Providing fasting blood samples for the measurement of glycemic and metabolic health markers. These include fasting plasma glucose, hemoglobin A1c (HbA1c), fasting insulin, and 2-hour oral glucose tolerance test (OGTT) results.
- Anthropometric Assessments: Undergoing standardized measurements of height, body weight, body fat percentage (via bioelectrical impedance), waist circumference, and Body Mass Index (BMI) at scheduled intervals.
- Questionnaires: Completing validated surveys to assess habitual dietary intake, sleep quality and duration, and levels of physical activity.
Investigators will compare changes in blood sugar control and other health measures from the start to the end of the 12-week study among the three groups.
详细描述
This study aims to investigate the effects of a Mediterranean-style diet combined with cycling and rowing exercises on blood sugar control and daily blood sugar fluctuations in women with prediabetes.
Prediabetes is a condition in which blood sugar levels are higher than normal but not high enough to be diagnosed as type 2 diabetes. Importantly, prediabetes can often be reversed with appropriate lifestyle changes. Healthy eating habits and regular physical activity are the most effective ways to prevent the progression from prediabetes to diabetes. However, commonly used blood sugar tests, such as fasting glucose and hemoglobin A1c (HbA1c), do not always reflect daily ups and downs in blood sugar levels.
For this reason, this study will use continuous glucose monitoring (CGM) in addition to standard blood tests. CGM is a small sensor placed on the upper arm that measures blood sugar levels continuously throughout the day and night. This method shows how long blood sugar stays within a healthy range and how much it fluctuates during daily life. These detailed measurements allow a more accurate evaluation of how diet and exercise affect blood sugar control.
One important feature of this study is that it examines not only the effect of diet but also the effects of two different types of exercise. Participants will first perform cycling exercises, which mainly involve the lower body, and then rowing exercises, which engage both the upper and lower body. This approach allows a comparison of how different exercise types influence blood sugar regulation. In addition, evaluation will be based on metabolic background.Women whose blood sugar levels have recently returned to normal will be compared with women who still have prediabetes to determine whether responses differ to the same lifestyle program.
The study will last 12 weeks and will include three groups based on blood sugar status and medical suitability for exercise. The diet-only group will consist of women with prediabetes who are not able to participate in structured exercise for medical reasons and will follow a Mediterranean diet for 12 weeks. The diet plus exercise group will include women with ongoing prediabetes who are medically able to exercise; these participants will follow the Mediterranean diet and perform supervised exercise three times per week for 8 weeks. The third group will consist of women who were diagnosed with prediabetes within the last year but whose blood sugar levels are normal at the start of the study. This group will follow the same diet and exercise program as the second group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the behavioral nature of lifestyle interventions (supervised exercise and diet counseling), it will not be possible to blind participants or personnel administering the interventions. However, the data analyst performing the statistical analyses will be unaware of information regarding group assignment. Analysis datasets will be anonymized with neutral codes before being provided to the analyst.
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having a diagnosis of prediabetes (within the last 1 year)
- •Impaired Fasting Glucose (IFG) 100-125 mg/dl
- •OGTT result 2-hour postprandial Impaired Glucose Tolerance (IGT) 140-199 mg/dl
- •HbA1c 5.7-6.4%
- •Being between 22-55 years of age
- •Being female
- •Body Mass Index 18-34.9 kg/m2
- •Meeting the criteria in the American College of Sports Medicine (ACSM) and American Heart Association (AHA) cardiovascular disease risk assessment scoring system
- •Not engaging in regular planned exercise or physical activity (sedentary)
排除标准
- •Being pregnant
- •No self-reported low iron concentrations or anaemia
- •Use of medication, insulin, or weight loss injections known to affect lipid and glucose metabolism
- •Presence of cardiovascular disease
- •Current smoking or excessive alcohol consumption
- •Presence of abnormal electrocardiogram (ECG)
- •Presence of autonomic neuropathy
- •Presence of uncontrolled hypertension (systolic blood pressure >135 mmHg, diastolic blood pressure >85 mmHg)
- •Joint-muscle-bone injury limiting exercise
研究组 & 干预措施
Active Prediabetes Exercise Group
Women with active prediabetes who are medically eligible for exercise will participate in a 12-week intervention including a Mediterranean-style diet throughout the study and a supervised 8-week sequential exercise program between Weeks 3 and 10. The exercise program will consist of cycling ergometer training during Weeks 3-6 and rowing ergometer training during Weeks 7-10. Participants will complete three supervised sessions per week, each lasting approximately 51 minutes.
Exercise intensity will be individualized using the Heart Rate Reserve (HRR) method, based on resting heart rate and maximal heart rate measured by a maximal Bruce protocol test. Each session will include a warm-up at 40% HRR, alternating intervals at 50% and 60% HRR with short recovery periods, and a cool-down at 40% HRR. Heart rate will be continuously monitored using a Polar H10 chest strap.
干预措施: Supervised Sequential Exercise (Behavioral)
Control Group
Women with medically documented prediabetes who are not eligible for the supervised exercise program for medical reasons. This arm serves as the primary comparison group and represents standard care. Participants will follow a 12-week individualized Mediterranean diet intervention emphasizing high intake of vegetables, fruits, whole grains, legumes, nuts, and olive oil; moderate consumption of fish and poultry; and low intake of red meat, processed foods, and sweets. Dietary counseling will be provided by a dietitian, and participants will complete food diaries. All participants will undergo the same scheduled assessments as the intervention arms, including blood tests, anthropometric measurements, questionnaires, and continuous glucose monitoring (CGM).
干预措施: Mediterranean Diet (Other)
Active Prediabetes Exercise Group
Women with active prediabetes who are medically eligible for exercise will participate in a 12-week intervention including a Mediterranean-style diet throughout the study and a supervised 8-week sequential exercise program between Weeks 3 and 10. The exercise program will consist of cycling ergometer training during Weeks 3-6 and rowing ergometer training during Weeks 7-10. Participants will complete three supervised sessions per week, each lasting approximately 51 minutes.
Exercise intensity will be individualized using the Heart Rate Reserve (HRR) method, based on resting heart rate and maximal heart rate measured by a maximal Bruce protocol test. Each session will include a warm-up at 40% HRR, alternating intervals at 50% and 60% HRR with short recovery periods, and a cool-down at 40% HRR. Heart rate will be continuously monitored using a Polar H10 chest strap.
干预措施: Mediterranean Diet (Other)
Remission Prediabetes Exercise Group
Participants in this arm are women with a documented diagnosis of prediabetes within the past year who are normoglycemic at screening according to American Diabetes Association (ADA) criteria and are medically eligible to participate in exercise. These participants will receive the same 12-week Mediterranean diet program and the same supervised 8-week sequential exercise intervention (cycling followed by rowing) as the active prediabetes exercise group.
干预措施: Mediterranean Diet (Other)
Remission Prediabetes Exercise Group
Participants in this arm are women with a documented diagnosis of prediabetes within the past year who are normoglycemic at screening according to American Diabetes Association (ADA) criteria and are medically eligible to participate in exercise. These participants will receive the same 12-week Mediterranean diet program and the same supervised 8-week sequential exercise intervention (cycling followed by rowing) as the active prediabetes exercise group.
干预措施: Supervised Sequential Exercise (Behavioral)
结局指标
主要结局
Change in Fasting Plasma Glucose (FPG)
时间窗: Baseline (week 0) and the end of the 12 weeks program (week 13)
Change in Fasting Plasma Glucose levels, measured in mg/dL from venous blood.
Change in 2-hour Oral Glucose Tolerance Test (OGTT) Glucose
时间窗: Baseline (week 0) and the end of the 12 weeks program (week 13)
Change in plasma glucose levels measured 2 hours after a standardized glucose load, measured in mg/dL from venous blood.
Change in Hemoglobin A1c (HbA1c)
时间窗: Baseline (week 0) and the end of the 12 weeks program (week 13)
Change in the percentage (%) of glycated hemoglobin (HbA1c) measured from venous blood.
Change in Fasting Insulin
时间窗: Baseline (week 0) and the end of the 12 weeks program (week 13)
Change in fasting serum insulin levels, measured in microinternational units per milliliter (µIU/mL) from venous blood. This measurement serves as an indicator of basal insulin secretion and insulin resistance.
次要结局
- Change in Body Weight(Baseline (Week 0), Weeks 2, 4, 6, 8, 10, and 12.)
- Change in Body Mass Index (BMI)(Baseline (Week 0), Weeks 2, 4, 6, 8, 10, and 12.)
- Change in Body Fat Percentage(Baseline (Week 0), Weeks 2, 4, 6, 8, 10, and 12.)
- Change in Waist-to-Hip Ratio(Baseline (Week 0), Weeks 2, 4, 6, 8, 10, and 12.)
- Change in Glycemic Variability (CV)(Exercise groups: Baseline (week 2) , Week 6, Week 10 and Week 13. Control group: Baseline (week 2) and Week 13.)
- Change in Continuous Glucose Monitoring (CGM)-Derived Time in Range (TIR)(First 10 days of the intervention, Last 10 days of the cycling phase (Weeks 5-6), Last 10 days of the rowing phase (Weeks 9-10), Final 10 days of the intervention.)
- Change in Continuous Glucose Monitoring (CGM)-Derived Time Above Range (TAR)(First 10 days of the intervention, Last 10 days of the cycling phase (Weeks 5-6), Last 10 days of the rowing phase (Weeks 9-10), Final 10 days of the intervention.)
- Change in Continuous Glucose Monitoring (CGM)-Derived Time Below Range (TBR)(First 10 days of the intervention, Last 10 days of the cycling phase (Weeks 5-6), Last 10 days of the rowing phase (Weeks 9-10), Final 10 days of the intervention.)
- Change in Mean Glucose(First 10 days of the intervention, Last 10 days of the cycling phase (Weeks 5-6), Last 10 days of the rowing phase (Weeks 9-10), Final 10 days of the intervention.)
- Change in Glucose Standard Deviation (SD)(First 10 days of the intervention, Last 10 days of the cycling phase (Weeks 5-6), Last 10 days of the rowing phase (Weeks 9-10), Final 10 days of the intervention.)
- Change in Coefficient of Variation (CV)(First 10 days of the intervention, Last 10 days of the cycling phase (Weeks 5-6), Last 10 days of the rowing phase (Weeks 9-10), Final 10 days of the intervention.)
- Change in Glucose Management Indicator (GMI)(First 10 days of the intervention, Last 10 days of the cycling phase (Weeks 5-6), Last 10 days of the rowing phase (Weeks 9-10), Final 10 days of the intervention.)
- Change in Area Under the Curve (AUC) for Glucose(First 10 days of the intervention, Last 10 days of the cycling phase (Weeks 5-6), Last 10 days of the rowing phase (Weeks 9-10), Final 10 days of the intervention.)
- Change in Mediterranean Diet Adherence (MEDAS Score)(Baseline (week 0) and the end of the 12 weeks program (week 13))
- Change in Sleep Quality (PSQI)(Baseline (week 0) and the end of the 12 weeks program (week 13))
研究者
Begüm Yücesoy Güneysu
PhD(c), Dietitian, Principal Investigator
Marmara University