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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
Sponsor:
Collaborators:
Danish Diabetes Academy
Region of Southern Denmark
Odense Patient Data Explorative Network
Novo Nordisk A/S
University of Southern Denmark
Information provided by (Responsible Party):
Aleksander Krag, Odense University Hospital

Brief Summary:

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

Detailed Description:

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:

  1. Improve glycemic control, dyslipidemia and metabolic markers in T2D despite unchanged anti-diabetic treatment.
  2. 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).
  3. 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.
  4. Improve quality of life
  5. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
No Intervention: Control-group
The control group will be eating a regular diabetes diet according to the Danish National Recommendations
Experimental: Intervention-group
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




Primary Outcome Measures :
  1. Glycemic control, dyslipidemia and metabolic markers [ Time Frame: Change from baseline at 6 months ]
    Measured by HbA1c, serum cholesterol, blood glucose and metabolic markers


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. Quality of life [ Time Frame: Change from baseline at 6 months ]
    Assessed by questionaire

  4. Gut dysbiosis [ Time Frame: Change from baseline at 6 months ]
    Assessed by fecal sample



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Duration of established T2D for more than six months and less than five years and HbA1c in compliance with T2D (above 48 mmol/mol), but without need for adjustment of antidiabetic treatment*
  2. Serum cholesterol below 4.5 mmol/l and LDL cholesterol below 2.5 mmol/l at inclusion**
  3. Age of 18 or above
  4. Stable diabetic treatment three months prior to inclusion***
  5. Be able to read and understand Danish language
  6. Signed written consent

    • based on the assumption that metabolic and cardiovascular changes are less likely to be reversible in patients with longstanding T2D. HbA1c and need for adjustment and if the patient is eligible for inclusion will be evaluated individually based on the patients current treatment and current HbA1c by the project responsible. If the patient has duration of diabetes > 5 years but with current treatment ≤ 2 oral antidiabetic drugs and without insulin treatment, the patient will be accepted for enrolment.

      • To avoid changes in lipid-lowering treatment during follow-up total cholesterol should be below 4.5 mmol/l and LDL cholesterol below 2.5 mmol/l at inclusion. Higher levels may be accepted if the patient cannot tolerate lipid-lowering treatment ***Patients can be enrolled three months after medication change

Exclusion Criteria:

  1. Low carbohydrate diet prior to inclusion
  2. Hypoglycemic unawareness
  3. Excessive weight loss within the last three months, defined as more than 10 kilograms
  4. Current treatment with glucocorticoids (systemic)
  5. Continuous treatment with steatosis-inducing drugs (e.g. carbamazepine)
  6. Treatment with antibiotics up to 2 months before inclusion*
  7. Treatment with chemotherapy
  8. Pregnancy or expected pregnancy within the next 6 months
  9. Active alcohol overuse**
  10. Active cancer
  11. Significant co morbidity including liver disease
  12. Poor compliance *Participants can be rescheduled to be included 2 months after use of antibiotics ** Prior alcohol overuse and eligibility will be evaluated individually

Information from the National Library of Medicine

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


Contacts
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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

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Danish Diabetes Academy
Region of Southern Denmark
Odense Patient Data Explorative Network
Novo Nordisk A/S
University of Southern Denmark
Investigators
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Principal Investigator: Henning Beck-Nielsen, Professor Odense University Hospital

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Responsible Party: Aleksander Krag, Professor, PhD, M.D., DMSc, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03068078     History of Changes
Other Study ID Numbers: S-20150217
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Liver Diseases
Atherosclerosis
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders