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New treatment option for Type 2 Diabetes
Official title GLycaemic Outcomes With Whey Protein in ageING
ClinicalTrials.gov ID: NCT07285811
What this study is testing
- What it's testing
- The goal of this placebo-controlled, partial crossover design study is to identify the impact of consuming whey protein before meals on free-living glucose control in older adults living with type 2 diabetes. The primary specific objective is to determine the effect of a thrice daily whey protein pre-meal supplementation at two doses, on glucose excursions over a 7-day free-living period in adults aged 75-90 years of age, living with type 2 diabetes, compared with a non-protein placebo.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 to 90. Healthy volunteers may be eligible.
You may be able to join if
- Male or female
- 75-90 years old
- Type 2 Diabetes (confirmed with glycated haemoglobin (HbA1c) \>6.5% in clinic or in SportExR)
- Stable body mass (body mass index (BMI) ≤40kg/m2)
- Generally healthy, assessed via a General Health Questionnaire (GHQ)
You likely can't join if
- \<75 years old and over 90 years of age
- Currently on fast-acting insulin therapy (i.e., Humalog)
- Confirmed uncontrolled diabetes (HbA1C \>10% or 85mmol/mol).
- Currently on GLP-1 therapy
- Habitual smoker or vaper
- Veganism
See the full eligibility criteria
- Male or female
- 75-90 years old
- Type 2 Diabetes (confirmed with glycated haemoglobin (HbA1c) \>6.5% in clinic or in SportExR)
- Stable body mass (body mass index (BMI) ≤40kg/m2)
- Generally healthy, assessed via a General Health Questionnaire (GHQ)
- Some residual beta-cell activity (confirmed with urine test on induction)
- Normal or moderately increased albuminuria (needs to be below 300mg/g)
- Normal, mildly or moderately decreased glomerular filtration rate (GFR) (needs to be above 45ml/min/1.732).
- Able and willing to attend SportExR a total of 5 times: 1 induction and 2 testing visits and 2 return check-up visits.
- \<75 years old and over 90 years of age
- Currently on fast-acting insulin therapy (i.e., Humalog)
- Confirmed uncontrolled diabetes (HbA1C \>10% or 85mmol/mol).
- Currently on GLP-1 therapy
- Habitual smoker or vaper
- Veganism
- Lactose or dairy intolerance
- Coeliac or gluten intolerance
- History of gastrointestinal disease
- Experienced a hyperglycaemic or hypoglycaemic event requiring treatment in the past 12 months
- Recent Ischemic stroke (\<3 months).
- Use of anticoagulants (e.g. warfarin, rivaroxaban)
- Considered unwilling or unable to comply with the study protocol requirements by the research team
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, West Midlands, United Kingdom
- Birmingham, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, West Midlands, United Kingdom; Birmingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.