Can a very low calorie diet (VLCD) induce remission in people with Type 2 diabetes?

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619001301156
• Lead Sponsor: Kathy Harrison

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-23
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.18 – 65 years of age
2.Able to provide informed consent
3.Duration of type 2 diabetes of less than 6 years.
4.HbA1c > than 6.5%
5.BMI >27kg/m2

Exclusion Criteria

1.Recent eGFR <30mls/min/1.73m2
2.Severe hepatic impairment
3.Alcohol or illegal substance dependence
4.Known cancer
5.Myocardial infarction within previous 6 months
6.Severe heart failure defined as equivalent to the NYHA grade 3
7.Diagnosed eating disorder or purging
8.Pregnancy and breastfeeding
9.Patients on insulin therapy
10.Patients on anti-obesity medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c as evidenced by serum assay[At 12 months post intervention]

Secondary Outcome Measures

Name	Time	Method
Change in weight by 10kg or more as assessed by measuring weight at 12 month appointment on a digital scale[At 12 months post intervention];Change in hypertension as evidenced by comparing measurements pre and post study at 12 months using an automated sphygmomanometer[At 12 months post intervention];change in renal function as assessed by serum assay and urine assay<br>serum albumin, creatinine and eGFR<br>urine albumin creatinine ratio[at 12 months post intervention];change in cholesterol as assessed by serum assay[at 12 months post intervention<br>]