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A study to assess a low volume meal test and a very low calorie diet in obese patients with type 2 diabetes, for the future study of bariatric surgery.

A pilot study to assess a low volume meal test to assess gut peptide physiology, and the tolerability and safety of a short term very low caloric restriction diet in obese patients with type 2 diabetes.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000423617
Enrollment
12
Registered
2014-04-17
Start date
2014-05-12
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This is a study of 2 research tools, the availability of which will allow more detailed studies exploring the mechanism underlying the improvements in diabetes control seen very early after bariatric (weight loss) surgery. Participants will be asked to undergo 2 liquid meal tests to assess whether a small volume meal test performs as well as a standard volume meal test in the assessment of gut hormones. Participants will also be calorie restricted for 4 days under supervision. The degree of calorie restriction is approximately 15% of the recommended daily intake and is comparable to the intake of calories seen within the first 5 days following bariatric surgery.

Interventions

12 participants will be recruited. The study comprises 2 sub studies (study 1 and study 2) and the same 12 participants will undertake both studies. For study 1, participants will be asked to attend our research centre on two separate days (within 7 days of eachother) where a liquid meal test will be performed. This involves the consumption by the participant of a liquid meal (similar to yoghurt in consistency, TWOCAL HN, Abbots nutrition, fat 39.4%, carbohydrate 43%, protein 16.8%, 2 calorie

12 participants will be recruited. The study comprises 2 sub studies (study 1 and study 2) and the same 12 participants will undertake both studies. For study 1, participants will be asked to attend our research centre on two separate days (within 7 days of eachother) where a liquid meal test will be performed. This involves the consumption by the participant of a liquid meal (similar to yoghurt in consistency, TWOCAL HN, Abbots nutrition, fat 39.4%, carbohydrate 43%, protein 16.8%, 2 calories/ml) within 10 minutes, and the collection of blood samples immediately before and then at 10,20,30,60,90,120,150, and 180 minutes after the drink is consumed. The volume of the liquid meal will differ between the 2 days (200ml and 50ml), and participants will be randomised as to which of the liquid meal volumes used in this study they undertake first. Study 2 will commence immediately after completion of the second liquid meal test for study 1, and involves participants adhering to a very low calorie diet for 4 days. Participants will be asked to consume no food or drink (with the exception of water) for the 96 hour period from the consumption of the liquid meal through to 8am on study day 6. They will be asked to attend our research unit daily during this time (study days 3-6) for an assessment (including a blood test) and the intravenous administration of 2000ml of dextrose solution (providing 340 calories). At 8am on study day 6 a third liquid meal test will be performed as above before the study is completed. The volume of the meal on consumed by each participant on study day 6 will be the same as taken on study day 2. Adherence to the intervention will be monitored through a daily interview and assessment.

Sponsors

Endocrine, diabetes and research centre
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. BMI >35 kg/m2 2. Type 2 diabetes treated with diet or tablets (Metformin and/or a Sulphonylurea) 3. HbA1c<86 mmol/mol

Exclusion criteria

1. Type 1 diabetes 2. Use of Insulin therapy 3. Recent significant weight change (> 5 kg over past 3 months) 4. Previous bariatric surgery 5. Currently pregnant or planning pregnancy within 3 months 6. Significant medical condition which, in the view of study investigators, would make recruitment in study inappropriate.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026