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Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study

Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02472951
Acronym
CutDM
Enrollment
30
Registered
2015-06-16
Start date
2015-08-31
Completion date
2017-12-31
Last updated
2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

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.

Interventions

Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%

Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Men age 18-70 years * Postmenopausal women age 55-70 years * Non-smoker (abstinent at least 6 months) * HbA1c \< 74 mmol/mol * Fasting blood glucose \< 11 mmol/L (mean of 3 measurements) * Negative (\<25 IU/L) plasma glutamate decarboxylase (GAD-65) antibodies (IgG) * Hemoglobin \> 7.5 mmol/L (men); \> 6.8 mmol/L (women) * Normal thrombocytes (140-400 x 109/L) * eGFR \> 45 ml/min per 1.73 m2 * Alkaline phosphatase \< 140 IU/L * Alanine aminotransferase \< 70 IU/L * Normal International Normalized Ratio (0.9-1.2)

Exclusion criteria

* Critical illness * Anti-diabetic drugs other than metformin (maximum of 2000 mg / day) * Steroid treatment e.g. prednisolone * Reported or journalized severe food allergy or intolerance * Reported or journalized gut disease e.g. Crohn's disease, Coeliac disease * Reported or journalized alcohol dependence syndrome

Design outcomes

Primary

MeasureTime frameDescription
Insulin sensitivityMeasured during meal tests (2 days with each intervention)Insulin sensitivity as measured by the oral minimal model applied to the meal test

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026