Type2 DiabetesReDuCtionNCT03068078
A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes
A study testing Low carbohydrate diet high in monounsaturated fats in people with Type2 Diabetes and Nonalcoholic Steatohepatitis, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes, Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Low carbohydrate diet high in monounsaturated fats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to 4 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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*
- Serum cholesterol below 4.5 mmol/l and LDL cholesterol below 2.5 mmol/l at inclusion**
- Age of 18 or above
- Stable diabetic treatment three months prior to inclusion***
- Be able to read and understand Danish language
- 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
Who cannot join
- Low carbohydrate diet prior to inclusion
- Hypoglycemic unawareness
- Excessive weight loss within the last three months, defined as more than 10 kilograms
- Current treatment with glucocorticoids (systemic)
- Continuous treatment with steatosis-inducing drugs (e.g. carbamazepine)
- Treatment with antibiotics up to 2 months before inclusion*
Show all 12Show fewer
- Treatment with chemotherapy
- Pregnancy or expected pregnancy within the next 6 months
- Active alcohol overuse**
- Active cancer
- Significant co morbidity including liver disease
- Poor compliance *Participants can be rescheduled to be included 2 months after use of antibiotics ** Prior alcohol overuse and eligibility will be evaluated individually
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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:
- 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.
- Conditions
- Type2 Diabetes, Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Atherosclerosis, Dyslipidemias
- Being tested
- Low carbohydrate diet high in monounsaturated fats
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Atherosclerosis, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate diet high in monounsaturated fatsDietary supplement
Also called LCD
Participants will have to change their diet during 6 months
| Study group | Role | What they receive |
|---|---|---|
| Control-group | No intervention | The control group will be eating a regular diabetes diet according to the Danish National Recommendations |
| Intervention-group | Experimental | Intervention-group will be eating a low carbohydrate diet, high in monounsaturated fats Receives: Dietary Supplement: Low carbohydrate diet high in monounsaturated fats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control, dyslipidemia and metabolic markers
Measured by HbA1c, serum cholesterol, blood glucose and metabolic markers
Measured: Change from baseline at 6 months
Secondary outcomes (4)
Endothelial function
assessed by FMD in the brachial artery as well as microvascular damage assessed by retinal scan, urine albuminuria and minimal forearm vascular resistance (MFVR).
Measured: Change from baseline at 6 months
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.
Measured: Change from baseline at 6 months
Quality of life
Assessed by questionaire
Measured: Change from baseline at 6 months
Gut dysbiosis
Assessed by fecal sample
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startNov 2016
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Diabetes Academy, Region of Southern Denmark, Odense Patient Data Explorative Network, Novo Nordisk A/S, University of Southern Denmark
- Responsible party
- Principal investigator, Aleksander Krag, Odense University Hospital
- Investigators
- Henning Beck-Nielsen, Professor, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068078
- Sponsor's protocol ID
- S-20150217
- Acronym
- ReDuCtion
- Status last verified
- Jul 2021
- First submitted
- 26 Jan 2017
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rasmussen JLP, Gram-Kampmann EM, Stidsen JV, Hansen CD, Krag A, Olsen MH, Beck-Nielsen H, Handberg A, Hojlund K. Effect of a 6-month low-carbohydrate diet on the circulating fatty acid composition in patients with type 2 diabetes: a secondary analysis of an open-label randomized controlled trial. Am J Clin Nutr. 2026 Sep;124(3):101400. doi: 10.1016/j.ajcnut.2026.101400. Epub 2026 Aug 14.
PubMed 42680257Petersen EE, Hansen JK, Torp N, Gram-Kampmann E, Andersen P, Johansen S, Villesen IF, Bech KT, Thorhauge KH, Schnefeld HL, Gjol CMB, Jensen EL, Detlefsen S, Hojlund K, Thiele M, Israelsen M, Krag A, Hansen CD. Health-related quality of life, compliance and sustained adherence on a low-carbohydrate high-fat diet compared with a high-carbohydrate low-fat diet in people with type 2 diabetes. Am J Clin Nutr. 2026 Apr;123(4):101211. doi: 10.1016/j.ajcnut.2026.101211. Epub 2026 Jan 27.
PubMed 41611090Wernberg CW, Indira Chandran V, Lauridsen MM, Skytthe MK, Hansen CD, Hansen JK, Gronkjaer LL, Jacobsen BG, Di Caterino T, Detlefsen S, Thiele M, Guiliani AM, Villesen IF, Leeming DJ, Karsdal M, Graversen JH, Krag A. Ability of soluble TREM2 and PRO-C3 as biomarkers to predict changes in MASLD activity. JHEP Rep. 2025 Apr 22;7(8):101432. doi: 10.1016/j.jhepr.2025.101432. eCollection 2025 Aug.
PubMed 40677693Gram-Kampmann EM, Olesen TB, Hansen CD, Hugger MB, Jensen JM, Handberg A, Beck-Nielsen H, Krag A, Olsen MH, Hojlund K. A six-month low-carbohydrate diet high in fat does not adversely affect endothelial function or markers of low-grade inflammation in patients with type 2 diabetes: an open-label randomized controlled trial. Cardiovasc Diabetol. 2023 Aug 17;22(1):212. doi: 10.1186/s12933-023-01956-8.
PubMed 37592243Hansen CD, Gram-Kampmann EM, Hansen JK, Hugger MB, Madsen BS, Jensen JM, Olesen S, Torp N, Rasmussen DN, Kjaergaard M, Johansen S, Lindvig KP, Andersen P, Thorhauge KH, Brond JC, Hermann P, Beck-Nielsen H, Detlefsen S, Hansen T, Hojlund K, Thiele MS, Israelsen M, Krag A. Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease : A Randomized Controlled Trial. Ann Intern Med. 2023 Jan;176(1):10-21. doi: 10.7326/M22-1787. Epub 2022 Dec 13.
PubMed 36508737
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03068078
- Acronym / sponsor ID
- ReDuCtion / S-20150217
- Conditions
- Type2 Diabetes, Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Atherosclerosis, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Danish Diabetes Academy, Region of Southern Denmark, Odense Patient Data Explorative Network, Novo Nordisk A/S, University of Southern Denmark
- Study start
- Nov 2016 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-group | No intervention | –The control group will be eating a regular diabetes diet according to the Danish National Recommendations |
| Intervention-group | Experimental | Dietary Supplement: Low carbohydrate diet high in monounsaturated fatsIntervention-group will be eating a low carbohydrate diet, high in monounsaturated fats |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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*
- Serum cholesterol below 4.5 mmol/l and LDL cholesterol below 2.5 mmol/l at inclusion**
- Age of 18 or above
- Stable diabetic treatment three months prior to inclusion***
- Be able to read and understand Danish language
Key exclusion criteria (12 listed)
- Low carbohydrate diet prior to inclusion
- Hypoglycemic unawareness
- Excessive weight loss within the last three months, defined as more than 10 kilograms
- Current treatment with glucocorticoids (systemic)
- Continuous treatment with steatosis-inducing drugs (e.g. carbamazepine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrate diet high in monounsaturated fatsAlso: LCDParticipants will have to change their diet during 6 months | Dietary supplement | Intervention-group |
Primary outcome
Glycemic control, dyslipidemia and metabolic markers
Time frame: Change from baseline at 6 months
Measured by HbA1c, serum cholesterol, blood glucose and metabolic markers
4 secondary outcomes
Endothelial function
Time frame: Change from baseline at 6 months
Non-Alcoholic Fatty Liver Disease (NAFLD)
Time frame: Change from baseline at 6 months
Quality of life
Time frame: Change from baseline at 6 months
Gut dysbiosis
Time frame: Change from baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 42680257Rasmussen JLP, Gram-Kampmann EM, Stidsen JV, Hansen CD, Krag A, Olsen MH, Beck-Nielsen H, Handberg A, Hojlund K. Effect of a 6-month low-carbohydrate diet on the circulating fatty acid composition in patients with type 2 diabetes: a secondary analysis of an open-label randomized controlled trial. Am J Clin Nutr. 2026 Sep;124(3):101400. doi: 10.1016/j.ajcnut.2026.101400. Epub 2026 Aug 14.
- Derived from this study: PubMed 41611090Petersen EE, Hansen JK, Torp N, Gram-Kampmann E, Andersen P, Johansen S, Villesen IF, Bech KT, Thorhauge KH, Schnefeld HL, Gjol CMB, Jensen EL, Detlefsen S, Hojlund K, Thiele M, Israelsen M, Krag A, Hansen CD. Health-related quality of life, compliance and sustained adherence on a low-carbohydrate high-fat diet compared with a high-carbohydrate low-fat diet in people with type 2 diabetes. Am J Clin Nutr. 2026 Apr;123(4):101211. doi: 10.1016/j.ajcnut.2026.101211. Epub 2026 Jan 27.
- Derived from this study: PubMed 40677693Wernberg CW, Indira Chandran V, Lauridsen MM, Skytthe MK, Hansen CD, Hansen JK, Gronkjaer LL, Jacobsen BG, Di Caterino T, Detlefsen S, Thiele M, Guiliani AM, Villesen IF, Leeming DJ, Karsdal M, Graversen JH, Krag A. Ability of soluble TREM2 and PRO-C3 as biomarkers to predict changes in MASLD activity. JHEP Rep. 2025 Apr 22;7(8):101432. doi: 10.1016/j.jhepr.2025.101432. eCollection 2025 Aug.
- Derived from this study: PubMed 37592243Gram-Kampmann EM, Olesen TB, Hansen CD, Hugger MB, Jensen JM, Handberg A, Beck-Nielsen H, Krag A, Olsen MH, Hojlund K. A six-month low-carbohydrate diet high in fat does not adversely affect endothelial function or markers of low-grade inflammation in patients with type 2 diabetes: an open-label randomized controlled trial. Cardiovasc Diabetol. 2023 Aug 17;22(1):212. doi: 10.1186/s12933-023-01956-8.
- Derived from this study: PubMed 36508737Hansen CD, Gram-Kampmann EM, Hansen JK, Hugger MB, Madsen BS, Jensen JM, Olesen S, Torp N, Rasmussen DN, Kjaergaard M, Johansen S, Lindvig KP, Andersen P, Thorhauge KH, Brond JC, Hermann P, Beck-Nielsen H, Detlefsen S, Hansen T, Hojlund K, Thiele MS, Israelsen M, Krag A. Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease : A Randomized Controlled Trial. Ann Intern Med. 2023 Jan;176(1):10-21. doi: 10.7326/M22-1787. Epub 2022 Dec 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Beck-Nielsen, Professor principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate diet high in monounsaturated fats in people with Type2 Diabetes and Nonalcoholic Steatohepatitis, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control, dyslipidemia and metabolic markers (time frame: Change from baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068078, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.