Can dietary changes lead to remission of type 2 diabetes even if a person does not lose weight?

Not Applicable

Suspended

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Type 2 diabetes mellitus

• Registration Number: ISRCTN26058700
• Lead Sponsor: niversity of Westminster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-26
• Study Completion: 2020-09-30
• Last Update Posted: 17 April 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

This study will recruit 15 people with type 2 diabetes and 15 people without type 2 diabetes

Inclusion criteria for all participants:
1. Males and post-menopausal females
2. Aged 45 to 60 years
3. BMI of 23 to 35 kg/m²
4. Reporting a stable weight for 3 months prior to study commencement
5. Must be able to give informed consent, and be willing to follow the diets as described in the telephone screening

Specific criteria for group with type 2 diabetes:
1. Must be diagnosed within the last 3 years
2. T2D must be diet-controlled or on metformin only

Specific criteria for group without type 2 diabetes:
1. Must have no family history of diabetes

Exclusion Criteria

1. Kidney disease
2. Type 1 diabetes
3. Liver disease
4. Hematologic abnormalities
5. Congestive heart failure
6. Untreated thyroid disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour glucose concentrations measured using the Dexcom G6 during the high protein versus the low protein dietary periods

Secondary Outcome Measures

Name	Time	Method
1. Fasting glucose concentrations measured using the Dexcom G6 during the high protein versus the low protein dietary periods<br>2. Post-prandial glucose concentrations for 3 hours following a meal (to be identified from the glucose profiles) measured using the Dexcom G6 during the high protein versus the low protein dietary periods<br>3. Mean amplitude of glucose excursions measured using the Dexcom G6 during the high protein versus the low protein dietary periods<br>4. High blood glucose index measured using the Dexcom G6 during the high protein versus the low protein dietary periods<br>5. Change in bodyweight measured using BlueTooth enabled scales from the first day to the last day of each low protein and high protein period<br>6. Mean steps per day measured by pedometer during the high protein versus the low protein dietary periods