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De klinische studie NCT02695810 voor Prediabetische toestand, Obesitas is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
The PRE-D Trial: Effect of Dapagliflozin, Metformin and Physical Activity in Pre-diabetes Fase 2 120 Korte termijn
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De klinische studie NCT02695810 onderzocht preventie bij Prediabetische toestand, Obesitas. Deze Fase 2 interventioneel studie is nu afgerond. Er werd gestreefd naar inclusie van 120 deelnemers vanaf 24 februari 2016. De studie werd geleid door Steno Diabetes Center Copenhagen en was gepland te worden voltooid op 13 januari 2019. Laatste update op ClinicalTrials.gov: 7 oktober 2019.
Beknopte samenvatting
The overall objective is to compare the short-term (3 months) effectiveness of three glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose variability, body composition, and cardiometabolic risk factors in overweight or obese individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).
Uitgebreide beschrijving
Different medical therapies and lifestyle modification for the prevention of type 2 diabetes have yet to be compared head-to-head in individuals with pre-diabetes. This research project will compare different glucose-lowering interventions in overweight and obese individuals with HbA1c levels in the pre-diabetic range.
Officiële titel
Effect of Dapagliflozin, Metformin and Physical Activity on Glucose Variability, Body Composition and Cardiovascular Risk in Pre-diabetes
Aandoeningen
Prediabetische toestandObesitasPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- 2015-001552-30
NCT-ID
Startdatum (Werkelijk)
2016-02-24
Laatste update geplaatst
2019-10-07
Verwachte einddatum
2019-01-13
Inschrijving (Geschat)
120
Studietype
Interventioneel
FASE
Fase 2
Status
Afgerond
Primaire doel
Preventie
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelDapagliflozin Dapagliflozin, 10 mg per day | Dapagliflozin 10 mg per day as monotherapy for 13 weeks |
Actieve comparatorMetformin Metformin, 2 x 850 mg per day | Metformine 2 x 850 mg per day as monotherapy for 13 weeks |
Actieve comparatorExercise Exercise, interval training | Oefening Interval training, 5 times per week, 30 min per session |
Geen interventieControl No intervention | N.v.t. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Mean amplitude of glycaemic excursions (MAGE) as assessed by continuous glucose monitoring | Change from baseline to 13 weeks and 26 weeks |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Intra-day glycaemic variability as assessed by continuous overall net glycaemic action (CONGA) | Change from baseline to 13 weeks and 26 weeks | |
Daily time spent above different glucose concentrations ( e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L) | Change from baseline to 13 weeks and 26 weeks | |
HbA1c | Change from baseline to 13 weeks and 26 weeks | |
Glucose concentrations during OGTT | Change from baseline to 13 weeks and 26 weeks | |
Insulin secretion as assessed by the insulinogenic index | Change from baseline to 13 weeks and 26 weeks | |
Insulin sensitivity as assessed by the insulin sensitivity index | Change from baseline to 13 weeks and 26 weeks | |
Body weight (kg) | Change from baseline to 13 weeks and 26 weeks | |
Body fat (%) as assessed by DEXA scan | Change from baseline to 13 weeks and 26 weeks | |
Cardiorespiratory fitness as assessed by maximal oxygen uptake (VO2 max) | Change from baseline to 13 weeks and 26 weeks | |
Respiratory exchange ratio (RER) as assessed by indirect calorimetry | Change from baseline to 13 weeks and 26 weeks | |
Basal metabolic rate (BMR) as assessed by indirect calorimetry | Change from baseline to 13 weeks and 26 weeks | |
Time spent sedentary and in moderate-to-vigorous physical activity intensity as assessed by accelerometer | Change from baseline to 13 weeks and 26 weeks | |
Systolic and diastolic blood pressure | Change from baseline to 13 weeks and 26 weeks | |
Plasma lipids | Change from baseline to 13 weeks and 26 weeks | |
Number of self-reported adverse events and side effects | Change from baseline to 13 weeks and 26 weeks | |
Self-rated health and quality of life as assessed by questionnaire | Change from baseline to 13 weeks and 26 weeks | |
Sleep habits as assessed by questionnaire | Change from baseline to 13 weeks and 26 weeks | |
Dietary intake as assessed by a food diary | Change from baseline to 13 weeks and 26 weeks | |
Adherence to the different interventions as assessed by number of tablets returned or number of training passes completed | Change from baseline to 13 weeks and 26 weeks | |
Responsiveness to interventions in individuals with different glucose tolerance status (impaired fasting glycaemia vs. impaired glucose tolerance) | Change from baseline to 13 weeks and 26 weeks |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
30 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
- HbA1c: from ≥5.7% (39 mmol/mol) to ≤6.4% (47 mmol/mol)
- Age: from ≥30 to ≤70 years of age
- BMI ≥25 kg/m2
- Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression;
- Current treatment with hormones which affect glucose metabolism;
- Current treatment with loop diuretics or thiazolidinediones;
- Current treatment with beta blockers or peroral steroids;
- Bariatric surgery within the past 2 years;
- Impaired renal function defined as an estimated GFR<60 ml/min/1.73m2;
- Neurogenic bladder disorders;
- Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion;
- Pregnant or lactating women;
- Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implants, hormonal vaginal ring, transdermal application, or intra-uterine devices;
- Allergic to one or more of the medications used in the study;
- Concomitant participation in other intervention study;
- Unable to understand the informed consent and the study procedures.
Steno Diabetes Center Copenhagen- 🧬Th...
Verantwoordelijke instantie
Kristine Færch, Hoofdonderzoeker, Senior Researcher, Steno Diabetes Center Copenhagen
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen
Steno Diabetes Center A/S, Gentofte Municipality, 2820, Denmark