Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03068078 |
Other study ID # |
S-20150217 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 2016 |
Est. completion date |
June 4, 2021 |
Study information
Verified date |
July 2021 |
Source |
Odense University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.