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NCT06144593 | RECRUITING | Diabetes Mellitus, Type 2

The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
Sponsor:

Hvidovre University Hospital

Information provided by (Responsible Party):

Kirstine Nyvold Bojsen-Moeller

Brief Summary:

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.

Condition or disease

Diabetes Mellitus, Type 2

Overweight and Obesity

Non-Alcoholic Fatty Liver Disease

Metabolic Syndrome

Intervention/treatment

Dietary macronutrient composition

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 14 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
Actual Study Start Date : 2024-01-03
Estimated Primary Completion Date : 2025-09-01
Estimated Study Completion Date : 2025-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Men or women
  • * 35-75 years old
  • * BMI \>27 kg/m2
  • * Known type 2 diabetes in stable glucose lowering therapy (for three months) or with HbA1c \>48 mmol/mol if no glucose lowering therapy
Exclusion Criteria
  • * Anemia (hemoglobin \<8 mmol/L for men and \<7 mmol/L for women)
  • * TSH outside reference range
  • * Treatment with insulin, sulfonylurea, or SGLT2-inhibitors
  • * Treatment with systemic corticosteroids
  • * HbA1c \>70 mmol/mol
  • * eGFR \<60 ml/min/1.73 m2
  • * Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
  • * Food allergies (including lactose and gluten intolerance)
  • * Vegetarian/vegan diet or following of specific dietary plans
  • * Alcohol consumptions \>84/168 g/week (women/men)
  • * Strenuous activity level \> 120 minutes per week
  • * Weight loss (\>5 kg) within the last three months or previous bariatric surgery
  • * High risk of fibrosis of the liver (estimated by FIB4 score \> 3.25)
The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes

Location Details

NCT06144593

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How to Participate

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Locations

RECRUITING

Denmark,

Department of Endocrinology, Hvidovre Hospital

Hvidovre, Denmark, 2650