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Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The investigators hypothesize that a lower carbohydrate content in the diabetic diet than the recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic factors like incretin hormones and decrease their insulinotropic effects due to their glucose dependency. This will reduce postprandial insulin concentration, resulting in an improved insulin sensitivity and glucose metabolism. This clinical study will examine in diabetic, prediabetic and healthy subjects the acute effects of short term highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to insulin action, pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in plasma and novel measures of fatty acid metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetic subjects | Active Comparator |
| |
| Prediabetic subjects | Active Comparator |
| |
| Healthy subjects | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low carbohydrate meals | Other | Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Insulin sensitivity as measured by the oral minimal model applied to the meal test | Measured during meal tests (2 days with each intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steen B Haugaard, MD, DMSc, associate prof. | Amager og Hvidovre Hospital | Study Director |
| Thure Krarup, MD, DMSc | Bispebjerg Hospital | Study Director |
| Amirsalar Samkani, MD | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinological Dept. Bispebjerg University Hospital | Copenhagen | Region Sjælland | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36061897 | Derived | Thomsen MN, Skytte MJ, Samkani A, Astrup A, Fenger M, Frystyk J, Hartmann B, Holst JJ, Larsen TM, Madsbad S, Magkos F, Rehfeld JF, Haugaard SB, Krarup T. Weight loss improves beta-cell function independently of dietary carbohydrate restriction in people with type 2 diabetes: A 6-week randomized controlled trial. Front Nutr. 2022 Aug 19;9:933118. doi: 10.3389/fnut.2022.933118. eCollection 2022. | |
| 32859328 |
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| Standard carbohydrate meals | Other | Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30% |
|
| Derived |
| Thomsen MN, Skytte MJ, Astrup A, Deacon CF, Holst JJ, Madsbad S, Krarup T, Haugaard SB, Samkani A. The clinical effects of a carbohydrate-reduced high-protein diet on glycaemic variability in metformin-treated patients with type 2 diabetes mellitus: A randomised controlled study. Clin Nutr ESPEN. 2020 Oct;39:46-52. doi: 10.1016/j.clnesp.2020.07.002. Epub 2020 Aug 1. |
| 30591062 | Derived | Samkani A, Skytte MJ, Anholm C, Astrup A, Deacon CF, Holst JJ, Madsbad S, Boston R, Krarup T, Haugaard SB. The acute effects of dietary carbohydrate reduction on postprandial responses of non-esterified fatty acids and triglycerides: a randomized trial. Lipids Health Dis. 2018 Dec 27;17(1):295. doi: 10.1186/s12944-018-0953-8. |
| 29644957 | Derived | Samkani A, Skytte MJ, Kandel D, Kjaer S, Astrup A, Deacon CF, Holst JJ, Madsbad S, Rehfeld JF, Haugaard SB, Krarup T. A carbohydrate-reduced high-protein diet acutely decreases postprandial and diurnal glucose excursions in type 2 diabetes patients. Br J Nutr. 2018 Apr;119(8):910-917. doi: 10.1017/S0007114518000521. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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