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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Danish Research Centre for Magnetic Resonance | OTHER |
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The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent carbohydrate restriction | Experimental | Four weeks of intermittent carbohydrate restriction: a dietary regime alternating between two days of restricting carbohydrate intake to 70-90 grams, while energy intake is ad libitum, from fat- and protein-containing foods, and two days of non-restricted diet. |
|
| Control arm | No Intervention | Four weeks of free-living with no dietary restrictions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary macronutrient composition | Other | Intermittent carbohydrate restriction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour average sensor glucose | A patient-blinded continuous glucose monitoring (CGM) is worn during the last two weeks of both the intervention and control period. | 24-hour average sensor glucose is measured as the average of eight consecutive days (starting from two days post sensor mounting) from the intermittent carbohydrate restriction period and the corresponding days of the control period (i.e. days 17-24). |
| Measure | Description | Time Frame |
|---|---|---|
| Liver triacylglycerol content | Liver TG content will be measured by 1H-Magnetic Resonance Spectroscopy (MRS) on the day before and the day after the 4-week dietary intervention (i.e. day 0 and day 30) and on the day before and the day after the 4-week control period (i.e. day 0 and day 30). | day 30 adjusted for baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Explorative outcomes - Questionnaires on quality of life | Participants will complete the questionnaires 'Problem Areas In Diabetes' & 'World Health Organisation-Five Well-Being Index'. | day 30 |
| Explorative outcomes - Qualitative evaluation to assess feasibility of the dietary strategy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Schaufuss, MSc | Contact | +4530270261 | amanda.schaufuss@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Hvidovre Hospital | Recruiting | Hvidovre | 2650 | Denmark |
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Dietary intervention
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| Fasting plasma concentrations of triacylglycerols |
Fasting plasma concentrations of triacylglycerols measured on the day before and the day after the 4-week dietary intervention (i.e. day 0 and day 30) and on the day before and the day after the 4-week control period (i.e. day 0 and day 30). |
| day 30 adjusted for baseline |
A semi-structured evaluation interview to assess social context, eating practices, compliance to, and feasibility and acceptability of the intermittent carbohydrate restriction regime will be carried out. |
| day 30 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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