A pilot study to look at the efficacy of a dietitian-led intervention using a homemade Very Low Calorie Diet (VLCD) to achieve prevention or remission of type 2 diabetes.

A pilot study to look at the efficacy of a dietitian-led intervention using a homemade Very Low Calorie Diet (VLCD) in patients with early Type 2 Diabetes or pre-diabetes, to achieve the outcomes of either prevention or remission of Type 2 Diabetes.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15555357

Enrollment

Registered

2021-09-07

Start date

2021-06-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention or reversal of type 2 diabetes in participants with pre-diabetes or type 2 diabetes diagnosed within the previous 4 years. Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

All participants will be recruited to the Homemade VLCD intervention and they will have baseline blood samples and anthropometric measurements done. In addition they will complete a health questionnai

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed written consent 2. Men and women with prediabetes (HbA1c 42 - 47 mmol/mol) 3. Men and women with Type 2 Diabetes, on diet, monotherapy or dual therapy within 4 years of diagnosis and not taking insulin 4. BMI >35kg/m² 5. Age 20 - 70years

Exclusion criteria

Exclusion criteria: 1. BMI 100mmol/mol 3. Insulin use 4. Pregnant or planning pregnancy 5. Diagnosed eating disorder 6. Renal function eGFR <30ml/min 7. Myocardial Infarction (MI) withing previous 6 months 8. Severe heart failure 9. Taking part in another research study 10. Cancer 11. Liver disease but not excluding Non Alcoholic Fatty Livr Disease (NAFLD) 12. Severe depression and those on antipsychotic medication 13. History of substance misuse

Design outcomes

Primary

Measure	Time frame
1. HbA1c is measured by Raigmore Hospital Biochemistry department at baseline, and 12, 24, 36, and 48 weeks. 2. Weight (kg) is measured at baseline, 12, 24, 36, and 48 weeks by NHS research nurse team staff using standard Diabetes clinic scales. 3. Waist circumference (cm) is measured at baseline, 12, 24, 36, and 48 weeks by NHS research nurse team staff using standard Diabetes clinic measuring tape. 4. BMI (kg/m²) is calculated, by research staff using height taken at baseline and weight at baseline 12, 24, 36, and 48 weeks.	—

Measure

Time frame

1. HbA1c is measured by Raigmore Hospital Biochemistry department at baseline, and 12, 24, 36, and 48 weeks. 2. Weight (kg) is measured at baseline, 12, 24, 36, and 48 weeks by NHS research nurse team staff using standard Diabetes clinic scales. 3. Waist circumference (cm) is measured at baseline, 12, 24, 36, and 48 weeks by NHS research nurse team staff using standard Diabetes clinic measuring tape. 4. BMI (kg/m²) is calculated, by research staff using height taken at baseline and weight at baseline 12, 24, 36, and 48 weeks.

—

Secondary

Measure	Time frame
1. Redoxiperoxin and Glutathione is analysed by UHI Division of Biomedical Sciences by way of a novel ALISA technique, Antibody linked Oxi-State Assay and/or HPLC-ECD. All samples will be stored on arrival in the UHI labs and batch analysed at the end of the collection period. 2. Diet Acceptability is measured by way of questionnaire at 4 weeks. 3. Self regulation of eating is measured at baseline, 12, 24, 36, and 48 weeks by way of Self Regulation of Eating Behaviour questionnaire (SREBQ) 4. Quality of life is measured at baseline, 12, 24, 36, and 48 weeks by way of Health Questionnaire EQ-5D-5L	—

Measure

Time frame

1. Redoxiperoxin and Glutathione is analysed by UHI Division of Biomedical Sciences by way of a novel ALISA technique, Antibody linked Oxi-State Assay and/or HPLC-ECD. All samples will be stored on arrival in the UHI labs and batch analysed at the end of the collection period. 2. Diet Acceptability is measured by way of questionnaire at 4 weeks. 3. Self regulation of eating is measured at baseline, 12, 24, 36, and 48 weeks by way of Self Regulation of Eating Behaviour questionnaire (SREBQ) 4. Quality of life is measured at baseline, 12, 24, 36, and 48 weeks by way of Health Questionnaire EQ-5D-5L

—

Countries

Scotland, United Kingdom

Contacts

Public ContactKirsty Hickson

kirsty.hickson@uhi.ac.uk+44 (0)1463 279575

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026