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Clinical Trials/ISRCTN15555357
ISRCTN15555357
Completed
未知

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.

niversity of the Highlands and Islands0 sites26 target enrollmentSeptember 7, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Prevention or reversal of type 2 diabetes in participants with pre-diabetes or type 2 diabetes diagnosed within the previous 4 years.
Sponsor
niversity of the Highlands and Islands
Enrollment
26
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 7, 2021
End Date
August 23, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of the Highlands and Islands

Eligibility 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

  • 1\. BMI \< 35 kg/m²
  • 2\. HbA1c \>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

Outcomes

Primary Outcomes

Not specified

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