A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes

NCT03068078 | Completed DMC

• 1 other identifier: S-20150217
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes; Nonalcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Atherosclerosis; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Glycemic control, dyslipidemia and metabolic markers

  Measured by HbA1c, serum cholesterol, blood glucose and metabolic markers

  Change from baseline at 6 months

Secondary Outcomes (4)

• Endothelial function

  Change from baseline at 6 months

• Non-Alcoholic Fatty Liver Disease (NAFLD)

  Change from baseline at 6 months

• Quality of life

  Change from baseline at 6 months

• Gut dysbiosis

  Change from baseline at 6 months

Study Arms (2)

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

Dietary Supplement: Low carbohydrate diet high in monounsaturated fats

Interventions

Low carbohydrate diet high in monounsaturated fats DIETARY_SUPPLEMENT

Participants will have to change their diet during 6 months

Also known as: LCD

Intervention-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*
• Age of 18 or above
• Be able to read and understand Danish language
• Signed written consent

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Danish Diabetes Academy: collaborator
• Region of Southern Denmark: collaborator
• Odense Patient Data Explorative Network: collaborator
• Novo Nordisk A/S: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (4)

• Petersen EE, Hansen JK, Torp N, Gram-Kampmann E, Andersen P, Johansen S, Villesen IF, Bech KT, Thorhauge KH, Schnefeld HL, Bastida Gjol CM, 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 Jan 27:101211. doi: 10.1016/j.ajcnut.2026.101211. Online ahead of print.

  PMID: 41611090 DERIVED

• Wernberg 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.

  PMID: 40677693 DERIVED

• Gram-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.

  PMID: 37592243 DERIVED

• Hansen 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.

  PMID: 36508737 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Atherosclerosis; Dyslipidemias

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Henning Beck-Nielsen, Professor

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, M.D., DMSc

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: March 1, 2017
• Study Start: November 1, 2016
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)