The SHAKE IT pilot study: Shakes and meal replacements to Help children and Adolescents Kick-start healthy Eating In Type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12616000375459
• Lead Sponsor: Professor Chris T Cowell

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Children and adolescents aged 7-18 years with a diagnosis of type 2 diabetes (fasting glucose >/=7.0 mmol/L and/or 2 hour glucose tolerance >/=11.1 mmol/L and/or HbA1c >/=6.5%) as defined by the American Diabetes Association.

Exclusion Criteria

1. Type 1 diabetes
2. Secondary causes of obesity
3. Psychiatric disturbance
4. On weight loss medications or medications known to cause weight gain (other than insulin)
5. Neither parent/ carer speaks English.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence/absence of type 2 diabetes<br>Assessed according to the American Diabetes Association criteria (i.e. an HbA1c >/= 6.5%, fasting plasma glucose >/= 7.0 mmol/L or a 2 hour post glucose load plasma glucose >/= 11.1 mmol/L) from fasting blood test and an oral glucose tolerance test.[Baseline<br>8 weeks<br>34 weeks];Change in body mass (continuous outcome) as assessed using calibrated digital scales to the nearest 0.1 kg.[Baseline<br>8 weeks<br>34 weeks]