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| Name | Class |
|---|---|
| The Novo Nordic Foundation | OTHER |
| Rigshospitalet, Denmark | OTHER |
| AstraZeneca | INDUSTRY |
| Bayer |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin, 10 mg per day |
|
| Metformin | Active Comparator | Metformin, 2 x 850 mg per day |
|
| Exercise | Active Comparator | Exercise, interval training |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | 10 mg per day as monotherapy for 13 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean amplitude of glycaemic excursions (MAGE) as assessed by continuous glucose monitoring | Change from baseline to 13 weeks and 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marit E Jørgensen, PhD | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center A/S | Gentofte Municipality | 2820 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24342268 | Background | Perreault L, Faerch K. Approaching pre-diabetes. J Diabetes Complications. 2014 Mar-Apr;28(2):226-33. doi: 10.1016/j.jdiacomp.2013.10.008. Epub 2013 Oct 28. | |
| 25877695 | Background | Faerch K, Hulman A, Solomon TP. Heterogeneity of Pre-diabetes and Type 2 Diabetes: Implications for Prediction, Prevention and Treatment Responsiveness. Curr Diabetes Rev. 2016;12(1):30-41. doi: 10.2174/1573399811666150416122903. |
| Label | URL |
|---|---|
| Steno Diabetes Center | View source |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009043 |
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| INDUSTRY |
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| Metformin | Drug | 2 x 850 mg per day as monotherapy for 13 weeks |
|
|
| Exercise | Behavioral | Interval training, 5 times per week, 30 min per session |
|
| 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 |
| 24743942 | Background | Faerch K, Vistisen D, Johansen NB, Jorgensen ME. Cardiovascular risk stratification and management in pre-diabetes. Curr Diab Rep. 2014 Jun;14(6):493. doi: 10.1007/s11892-014-0493-1. |
| 33705389 | Derived | Hulman A, Foreman YD, Brouwers MCGJ, Kroon AA, Reesink KD, Dagnelie PC, van der Kallen CJH, Greevenbroek MMJV, Faerch K, Vistisen D, Jorgensen ME, Stehouwer CDA, Witte DR. Towards precision medicine in diabetes? A critical review of glucotypes. PLoS Biol. 2021 Mar 11;19(3):e3000890. doi: 10.1371/journal.pbio.3000890. eCollection 2021 Mar. |
| 33064182 | Derived | Faerch K, Blond MB, Bruhn L, Amadid H, Vistisen D, Clemmensen KKB, Vaino CTR, Pedersen C, Tvermosegaard M, Dejgaard TF, Karstoft K, Ried-Larsen M, Persson F, Jorgensen ME. The effects of dapagliflozin, metformin or exercise on glycaemic variability in overweight or obese individuals with prediabetes (the PRE-D Trial): a multi-arm, randomised, controlled trial. Diabetologia. 2021 Jan;64(1):42-55. doi: 10.1007/s00125-020-05306-1. Epub 2020 Oct 16. |
| 28592573 | Derived | Faerch K, Amadid H, Nielsen LB, Ried-Larsen M, Karstoft K, Persson F, Jorgensen ME. Protocol for a randomised controlled trial of the effect of dapagliflozin, metformin and exercise on glycaemic variability, body composition and cardiovascular risk in prediabetes (the PRE-D Trial). BMJ Open. 2017 Jun 6;7(5):e013802. doi: 10.1136/bmjopen-2016-013802. |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |