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ID
Source
Brief title
Health condition
Type 2 diabetes
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter in this study consists of continuous measured glucose values (mmol/l) measured over a period of 180 days with the use of a CE approved continuous glucose sensor (Dexcom G6).
Secondary outcome
1. Daily food and drink intake
2. Wellbeing
3. Physical Activity: heart rate, type of exercise, onset and duration of exercise, and energy expenditure
4. Sleep: sleep duration, sleep onset, awakening time, and sleep quality
5. Anthropometric measurements: weight (kg), BMI (kg/m2), waist and hip circumference (cm), waist/hip ratio and blood pressure (mmHg)
6. Oral glucose tolerance test (OGTT): both glucose and insulin levels will be measured using a venous blood sample.
7. Clinical chemistry: average glucose levels (HbA1c), c-peptide, lipid profile (total cholesterol, HDL, LDL, triglycerides, free fatty acids) and C-reactive protein (CRP in mg/l)
Background summary
Rationale: Type 2 diabetes mellitus (T2D) is not a homogeneous disease; individuals with T2D might benefit from different types of lifestyle interventions, depending on the underlying physiology. Therefore, personalization is of crucial importance for clinical care, as we know that the physiological response to environmental cues (i.e. food, exercise, sleep, stress) and lifestyle interventions (e.g. low-carb or Mediterranean diet) is highly variable between individuals.
Evidence shows that CGM can promote reductions in HbA1c, body weight, and caloric intake, better adherence to a personal eating plan, and an increase in physical activity (PA). When integrated with education, these benefits may be further enhanced. This education becomes particularly powerful when it is personalized, meaning that an individual patient is given information about his or her own glycemic pattern and how this responds to what he or she does (e.g. food intake, PA, and sleep pattern) or experiences (e.g. stress)
Objective: Understand the relation between blood glucose levels and patterns, and contextual data in people with type 2 diabetes
Study design: This study will be an uncontrolled trial with 40 participants. The study will last 27 weeks, and consist of three observational phases (week 2, 13 and 24) and eight intervention phases, with a minimum of 1-week wash-out periods between all phases.
Study population: Insulin-naïve type 2 diabetes patients treated either by metformin or lifestyle advice.
Intervention: During the eight intervention phases participants will be subjected to lifestyle interventions for 4 days, to induce glycaemic variations in response to lifestyle changes including nutrition and exercise. Four different schemes will be used that will each be repeated twice:
1. Hourly physical activity: reducing sedentary time by being physically active for 5 minutes every hour between 09:00 and 17:00
2. After meal walk: 15-minute walk after breakfast, lunch and diner
3. Low carb: diet with a low amount of carbohydrates (sugar and starch).
4. Mediterranean diet: healthy eating plan high in fruits, vegetables, nuts, fish, whole grain and olive oil.
Main study parameters/endpoints: Continuously measured blood glucose values in mmol/l, food intake (food products/meals, macronutrient energy percentage, calories), heart rate (bpm), PA (duration, type), sleep (duration, quality).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of this study consists of application, use and removal of an implantable glucose monitors, 3 oral glucose tolerance tests and registering contextual factors. During the intervention phases participants are also requested to follow an intervention i.e. regular walking or eating according to the meal plan that is provided.
The risks associated with participation can be considered negligible, and are mainly associated with the glucose sensor and the OGTT. The glucose sensor provides a small risk of adverse events including skin irritation, skin infection and skin colouring. The OGTT poses a small risk of hypo- or hyperglycaemia and can lead to nausea.
Benefits include that participants can get more insight in their individual health behaviour and status by self-monitoring food intake, glucose levels, wellbeing and physical activity. Additionally, the use of continuous glucose monitoring and the prescribed interventions are associated with improved health outcome in type 2 diabetes.
Study objective
The study builds on the hypothesis that dense longitudinal personal and functional health data provide optimal information to feed algorithms to give better insight into the influence of contextual data (diet, physical activity, sleep, stress) on glucose metabolism on an individual basis.
The objective of this project is to gain a better understanding of the relation between blood glucose levels and patterns, and contextual data in individuals with T2D. An enhanced understanding of this relation can provide insights on how individuals with T2D can modify their lifestyle to improve glycaemic control.
Additionally, it is aimed to assess how different lifestyle interventions that are proven effective on a population level (Mediterranean diet, low-carb diet, PA) affect glucose fluctuations and specific CGM parameters for individuals.
Study design
screening (week -1), Visit 0 (week 0), Visit 1 (week 2), Visit 2 (week 13), Visit 3 (week 24), Visit 4 (week 27)
Intervention
Several interventions are introduced to induce a glucose response. These interventions will take a total of 4 days of which 3 are week days and 1 is a weekend day.
The following interventions are performed twice by each participant in a randomized order
1. Hourly physical activity: reducing sedentary time by being physically active for 5 minutes every hour between 09:00 and 17:00
2. After meal walk: 15-minute walk after lunch and diner
3. Low carb: A diet with a low amount of carbohydrates
4. Mediterranean diet: A healthy eating plan with high fruits, vegetable, nuts, fish, whole grain and olive oil.
The exact days at which the intervention is performed is flexible to allow participant to fit it into their daily lives, with the only limit that the different interventions must be at least a week apart as a wash-out period.
Inclusion criteria
• BMI 25 – 40 kg/m2, with preference for < 35 kg/m2
• Diagnosed with type 2 diabetes mellitus
• Insulin naïve
• Using either lifestyle and/or metformin for managing their diabetes
• In possession of a Smartphone running on a recent version of iOS or Android
• Able and willing to sign the informed consent form
• Willing to comply with all study procedures
Exclusion criteria
• Insufficient motivation to be in the study
• Unavailability for more than 2 weeks in a row during the study period
• History of bariatric weight loss surgery
• Planned (bariatric) surgery in the upcoming 6 months
• Active cancer or chemotherapy or radiation within 2 years prior to participation
• Chronic medical condition, treatment, or medication other than diabetes that may affect glucose metabolism (HIV diagnosis, use of steroids or immunosuppressive drugs, etc.)
• Chronic anaemia (haemoglobin of 6.2 mmol/l or less)
• Use of antibiotics or fertility treatments within 3 months prior to participation
• Pregnancy or a pregnancy wish
• 4 or more alcoholic drinks per day on a regular basis or use of recreational drugs
• Skin allergy, eczema or known sensitivity for plasters
• Coeliac or Crohns’ disease
• Food allergies or intolerances including, gluten, wheat, egg, (pea)nuts, celery, sesame, soy, cacao, glutamate, legumes, coriander, maize, (shell)fish, chicken, beef, pork, lamb, sulphites, lupine, milk and lactose
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7848 |
| CCMO | NL70771.028.19 |
| OMON | NL-OMON49104 |