A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes (ReDuCtion)
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|ClinicalTrials.gov Identifier: NCT03068078|
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : March 13, 2019
Further studies are needed to establish the optimal diet for treating T2D.
The investigators wishes to investigate whether a low carbohydrate diet, high in monounsaturated fats (LCD) will affect cardiovascular function, metabolism and the liver.
135 participants with T2D, will be following either a LCD, or a regular diabetes diet (RDD) for 6 months. Measurements and investigations will be performed at baseline and after 6 months.
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes Nonalcoholic Steatohepatitis Non-Alcoholic Fatty Liver Disease Atherosclerosis Dyslipidemias||Dietary Supplement: Low carbohydrate diet high in monounsaturated fats||Not Applicable|
Type 2 diabetes (T2D) is an increasing global problem, especially in developing countries. T2D is associated with an increased risk of cardiovascular disease (CVD), where hyperglycemia is especially important for microvascular damage.
Previous studies in T2D on reduced carbohydrate intake has shown beneficial effects on glycemic control, indicated by reduction in HbA1c, fasting insulin and 2h-glucose (OGTT) values. However further studies are needed to establish the optimal diet for treating T2D.
The investigators wishes to investigate whether a low carbohydrate diet, high in monounsaturated fats will:
- Improve glycemic control, dyslipidemia and metabolic markers in T2D despite unchanged anti-diabetic treatment.
- Improve endothelial function assessed by flow-mediated vasodilation (FMD) in the brachial artery as well as microvascular damage assessed by retinal scan, urine albuminuria and minimal forearm vascular resistance (MFVR).
- Improve Non-Alcoholic Fatty Liver Disease (NAFLD) assessed by >2 points reduction in NAFLD Activity score with at least 1 point reduction in either lobular inflammation or hepatocellular ballooning, without worsening of fibrosis.
- Improve quality of life
- Improve gut dysbiosis
The study will be conducted through a 6 month randomized controlled trial with 135 participants with type 2 diabetes. 90 participants will be randomized to the intervention group, following a LCD, and 45 participants will be randomized to the control group (regular diet for diabetes, RDD). The below described measurements will be conducted before baseline and after 6 months, and the participants will fill out a QoL questionnaire at 0, 3 and 6 months.
Planned examinations are ultrasound assessment of flow-mediated vasodilation, Dual-energy X-ray absorptiometry (DEXA-scan), retina scan, liver biopsy, liver-scans, blood, urine, hair, saliva and feces. Accelerometers will be applied before, during and after the study to evaluate compliance in unchanged exercise pattern. Compliance with diet will be evaluated by a clinical dietitian and through food diaries.
Baseline histology from the first 50 participants suggest that the current inclusion criteria doesn't cover the full spectrum of NAFLD (NASH and fibrosis) as expected. Further 50 participants who will have had diabetes for more than 10 years and who will not fulfill inclusion criteria number 1 and 2 will be included. On this group of participants we will only perform liver-investigations and DEXA-scan. This group of participants, will not affect the timeschedule of the main study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes: a Six-month Study of Changes in Metabolism, Liver- and Cardiovascular Function (ReDuCtion)|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
No Intervention: Control-group
The control group will be eating a regular diabetes diet according to the Danish National Recommendations
Intervention-group will be eating a low carbohydrate diet, high in monounsaturated fats
Dietary Supplement: Low carbohydrate diet high in monounsaturated fats
Participants will have to change their diet during 6 months
Other Name: LCD
- Glycemic control, dyslipidemia and metabolic markers [ Time Frame: Change from baseline at 6 months ]Measured by HbA1c, serum cholesterol, blood glucose and metabolic markers
- Endothelial function [ Time Frame: Change from baseline at 6 months ]assessed by FMD in the brachial artery as well as microvascular damage assessed by retinal scan, urine albuminuria and minimal forearm vascular resistance (MFVR).
- Non-Alcoholic Fatty Liver Disease (NAFLD) [ Time Frame: Change from baseline at 6 months ]Assessed by >2 points reduction in NAFLD Activity score with at least 1 point reduction in either lobular inflammation or hepatocellular ballooning, without worsening of fibrosis.
- Quality of life [ Time Frame: Change from baseline at 6 months ]Assessed by questionaire
- Gut dysbiosis [ Time Frame: Change from baseline at 6 months ]Assessed by fecal sample
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068078
|Contact: Eva Gram-Kampmann, MD||0045 21841795||Eva.Gram-Kampmann@rsyd.dk|
|Contact: Camilla D. Hansen, MD-student||0045 20646430||Camilla.Dalby.Hansen@rsyd.dk|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Principal Investigator:||Henning Beck-Nielsen, Professor||Odense University Hospital|