Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05581043 |
| Other study ID # |
V4_03052022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 12, 2023 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
October 2022 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Hyperglycemia following meals in patients with type 2 diabetes mellitus (T2DM) is a common
problem. Recently, our group found that oral consumption of the ketone metabolite,
3-hydroxybutyrate (3-OHB), effectively stimulates insulin secretion and delays gastric
emptying.The aim of this study is to investigate the dose/response relationship between 3-OHB
servings of 0, 10, 20 and 40 grams 30 minutes before an OGTT and, ii) investigate the role of
timing by serving 20 grams of 3-OHB at different timepoints ahead of an OGTT (0, 30 and 60
minutes)
Description:
Hyperglycemia following meals in patients with type 2 diabetes mellitus (T2DM) is a common
problem, which can cause discomfort and fatigue but may also lead to diabetic complications.
Small servings of macronutrients, especially protein-rich products, before a main meal (=
pre-meals) has been shown to significantly lower postprandial glucose excursions in both
healthy individuals and patients with T2DM. The reductions are primarily attributed the fact
that protein stimulates insulin secretion and delays gastric emptying. The timing and dose of
a premeal are essential for the glycemic reductions following a meal 4. Unfortunately, it
often requires a rather large amount of protein (> 50 g) to facilitate clinically relevant
reductions in postprandial glucose levels and a large protein intake may be unwanted for some
patients (i.e., chronic kidney disease). Recently, our group found that oral consumption of
the ketone metabolite, 3- hydroxybutyrate (3-OHB), effectively stimulates insulin secretion
and delays gastricemptying. We have also shown that 3-OHB inhibits gluconeogenesis 6, which
may further contribute to glucose-lowering effects. Two other clinical studies have shown
that serving 3- OHB before an oral glucose tolerance test (OGTT) lowered glucose excursions
in healthy volunteers and persons with impaired glucose tolerance. There are no current data
available about the effect of 3-OHB premeals in T2DM patients, but we have preliminary data
from an ongoing trial showing that 30 g of 3-OHB served 40 min before a mixed meal test
effectively lowers postprandial glucose levels (around 3 mM) in patients with T2DM. The
optimal dose and timing of 3-OHB pre-meals is unknown but important before initiating
long-term clinical trials. We hypothesize that pre-melas of 3-OHB will affect
postprandialglucose excursions in a time-dependent matter and servings 30 minutes before an
OGTT is Deleted: 4 optimal in order to lower postprandial glucose excursions. The aim of this
study is therefore to i) investigate the dose/response relationship between 3-OHB servings of
0, 10, 20 and 40 grams 30 minutes before an OGTT and, ii) investigate the role of timing by
serving 20 grams of 3-OHB at different timepoints ahead of an OGTT (0, 30 and 60 minutes).
The primary endpoint is glucose trajectories following the OGTT. This study will give
important insight into the optimal dose and timing for potential future clinical long-term
studies in patients with metabolic diseases (i.e., T2DM, obesity)
