overweight pre-diabetes
Conditions
Interventions
1. Dietary intervention
A. The energy restricted LCD diet (for adults only) consists of 800-1000 kcal/d
and the target macronutrient composition of the diet will be 15-20% of total
energy from fat,
Sponsors
Universiteit Maastricht
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults: age between 25 and 70; BMI > 25kg/ m2; The criteria from IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal inclusion criteria, i.e. having Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6-6.9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 * 11.0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT). Children: age 10-18 HOMA-IR has to be >
Exclusion criteria
Exclusion criteria: 1) Diabetes mellitus 2) Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease 3) Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months; 4) Advanced chronic renal impairment; 5) Significant liver disease e.g. cirrhosis (fatty liver disease allowed); 6) Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed); 7) Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsoption; 8) Previous bariatric surgery; 9) Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program); 10) A recent surgical procedure until after full convalescence (investigators judgement); 11) Transmissible blood-borne diseases e.g. hepatitis B, HIV; 12) Psychiatric illness (e.g. major depression, bipolar disorder).;Medication: 13) Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months. ;Personal/Other: 14) Engagement in competitive sports; 15) Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening; 16) Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed; 17) Severe food intolerance expected to interfere with the study; 18) Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women); children under 16 more than 0 glasses per week and children older than 16 more than 10 glasses per week. 19) Use of drugs of abuse within the previous 12 months; 20) Blood donation or transfusion within the past 1 month before baseline or CID*s; 21) Self-reported eating disorders; 22) Pregnancy or lactation, including plans to become pregnant within the next 36 months. 23) No access to either phone or Internet (this is necessary when being contacted by the instructor*s during the maintenance phase); 24) Inadequate understanding of national language; Psychological or behavioural problems, which, in the judgement of the investigator, would lead to difficulty in complying with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For adults: Incidence of type 2 diabetes, in a combination of protein and physical activity combinations, measured during 3 years after baseline and based on WHO/IDF criteria: * Fasting plasma glucose (FPG) > 7.0 mmol/l (126 mg/dl) or, * 75 g oral glucose tolerance test (OGTT) with FPG > 7.0 mmol/l (126 mg/dl) and/or 2 hour plasma glucose > 11.1 mmol/l (200 mg/dl) or, Sub study parameter/endpoint * Fat distribution by MRS (TWO study arms) * Physical fitness (VO2 max) (TWO study arms) * Brain reward activity by fMRI (TWO study arms) * Substrate metabolism with respiration chamber (TWO study arms) For children and adolescents: Change in insulin resistance at 2 years after randomization to a combination of protein diet and physical activity, measured by the homeostatic model (HOMA-IR). | — |
Secondary
| Measure | Time frame |
|---|---|
| For adults: * The effects of vigorous vs. moderate intensity physical activity on incidence of type 2 diabetes, based on WHO/IDF criteria (adjusted for diet); * Change in HbA1c, a measure of average blood glucose levels; * Change in body weight and waist, hip and thigh circumference; * Change in body fat mass (kg measured by BodPod, proportion of body weight); * Proportion of subjects maintaining at least 0, 5 or 10% weight loss (relative to initial body weight); * Insulin sensitivity (e.g. Matsuda Index based on the OGTT, glucose and insulin area under the curve (AUC) during OGTT, beta-cell disposition index) * Risk factors for cardiovascular disease, with at least the following measures: blood pressure, lipids (triglycerides, total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol), C-reactive protein, and liver enzymes; * Changes in perceived quality of life and workability, habitual well-being, and chronic stress, subjective appetite sensations, and habitual physical activity. * Effect of circadian rhythm on weight maintenance. For children and adolescents: * Change in body fat mass (kg, proportion of body weight) * Sleep architecture | — |
Countries
Netherlands
Outcome results
None listed