Postprandial Glycemia, Pregnancy
Conditions
Keywords
postprandial glucose excursions, glycemia, whey protein, protein pre-load, pregnancy, gestational diabetes mellitus, insulin secretion, incretins
Brief summary
This pilot study aims to investigate the intake of whey protein prior to carbohydrate intake as an approach to modulate postprandial glucose excursions during pregnancy.
Detailed description
Gestational diabetes (GDM) has transgenerational health consequences and increases the risk of type 2 diabetes mellitus in both mother and child. However, there is a lack of practical nutritional concepts for the prevention and treatment of GDM. This randomized controlled pilot study investigates whether the intake of a protein drink before carbohydrate intake lowers postprandial blood glucose levels of pregnant women. Therefore, two 75g oral glucose tolerance tests are performed in 20 pregnant women in a cross-over design, whereby a whey protein solution is drunk 30 minutes before one of the oral glucose tolerance tests (OGTT). If a clinically relevant effect on blood glucose levels is identified, this project can clarify whether the reduction in postprandial glycemia was caused by changes in the secretion of insulin and incretins.
Interventions
DIETARY_SUPPLEMENTWhey protein-preload OGTT
Intake of 25 g whey protein diluted in water 30 minutes prior to the start of a regular 75 g oral glucose tolerance test
Sponsors
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Each participant will undergo two oral glucose tolerance tests (i) one with whey protein pre-load and (ii) one without, in a randomized order.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women between 24+0 and 27+6 (+/- 7 days) weeks of pregnancy after menstruation * BMI before pregnancy: 18 - 29.9 kg/m2 * No known underlying diseases * Understanding and voluntary signing of a consent form before study-related examinations
Exclusion criteria
* Age \< 18 years * Diabetes mellitus type 1 or type 2 * Drug therapy that raises or lowers blood sugar, e.g. steroids, antidiabetics, insulin. * Endocrine disorders (e.g. hyperthyroidism, polycystic ovary syndrome (PCOS), ...) * Current depression or other mental illnesses * Eating disorder * Regular intake of medication other than vitamins/trace elements during pregnancy * Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m² * C-reactive protein \> 10 mg/l * Transaminase elevation of 2 times the upper norm * Pre-existing cardiac diseases * Drug and/or alcohol abuse * Hb \< 12 g/dl * No consent to be informed about incidentally discovered pathological findings * Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose course | Timepoint 0-120 minutes during the oral glucose tolerance test. | Course of plasma glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women. |
| Postprandial glucose excursion | Timepoint 0-120 minutes during the oral glucose tolerance test. | Area under the glucose curve (AUC 0-30 Min. and AUC 0-120 Min.) and peak glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin course | Timepoint 0-120 minutes during the oral glucose tolerance test. | Course of insulin assessed during the 75 g oral glucose tolerance test in pregnant women. |
| Insulin sensitivity | Timepoint 0-120 minutes during the oral glucose tolerance test. | Insulin sensitivity assessed during the 75 g oral glucose tolerance test in pregnant women. |
| Glucagon course | Timepoint 0-120 minutes during the oral glucose tolerance test. | Course of glucagon and area under the glucagon curve assessed during the 75 g oral glucose tolerance test in pregnant women. |
| C-peptide course | Timepoint 0-120 minutes during the oral glucose tolerance test. | Course C-peptide assessed during the 75 g oral glucose tolerance test in pregnant women. |
| GIP course | Timepoint 0-120 minutes during the oral glucose tolerance test. | Course of glucose-dependent insulinotropic polypeptide (GIP) and area under the GIP curve assessed during the 75 g oral glucose tolerance test in pregnant women. |
| Glicentin course | Timepoint 0-120 minutes during the oral glucose tolerance test. | Course of glicentin and area under the glicentin curve assessed during the 75 g oral glucose tolerance test in pregnant women. |
| GLP-1 course | Timepoint 0-120 minutes during the oral glucose tolerance test. | Course of glucagon-like peptide 1 (GLP-1) and area under the GLP-1 curve assessed during the 75 g oral glucose tolerance test in pregnant women. |
| Insulin secretion | Timepoint 0-120 minutes during the oral glucose tolerance test. | Insulin secretion assessed during the 75 g oral glucose tolerance test in pregnant women. |
Countries
Germany
Outcome results
None listed