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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes. The Hypo-energetic Study

NCT03814694

Diabetes Mellitus, Type 2 Overweight and Obesity

COMPLETED NA

Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus

NCT02459496

Type 2 Diabetes NAFLD Obesity +2 more

UNKNOWN NA

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

NCT06144593

Diabetes Mellitus, Type 2 Overweight and Obesity Non-Alcoholic Fatty Liver Disease +1 more

RECRUITING NA

A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes

NCT02559479

Weight Loss Obesity Diabetes +3 more

UNKNOWN NA

A Trial of Two Diets for Weight and Diabetes Management

NCT00729196

Type 2 Diabetes Mellitus Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Type 2 diabetic subjects

Group Type ACTIVE_COMPARATOR

Low carbohydrate meals

Intervention Type OTHER

Meal macronutritional energy composition:

Carbohydrate 30% Protein 30% Fat 40%

Standard carbohydrate meals

Intervention Type OTHER

Meal macronutritional energy composition:

Carbohydrate 55% Protein 15% Fat 30%

Prediabetic subjects

Group Type ACTIVE_COMPARATOR

Low carbohydrate meals

Intervention Type OTHER

Meal macronutritional energy composition:

Carbohydrate 30% Protein 30% Fat 40%

Standard carbohydrate meals

Intervention Type OTHER

Meal macronutritional energy composition:

Carbohydrate 55% Protein 15% Fat 30%

Healthy subjects

Group Type ACTIVE_COMPARATOR

Low carbohydrate meals

Intervention Type OTHER

Meal macronutritional energy composition:

Carbohydrate 30% Protein 30% Fat 40%

Standard carbohydrate meals

Intervention Type OTHER

Meal macronutritional energy composition:

Carbohydrate 55% Protein 15% Fat 30%

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low carbohydrate meals

Meal macronutritional energy composition:

Carbohydrate 30% Protein 30% Fat 40%

Intervention Type OTHER

Standard carbohydrate meals

Meal macronutritional energy composition:

Carbohydrate 55% Protein 15% Fat 30%

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes