The Impact of Myo-Inositol on Glycemic Control and Oxidative Stress in Gestational Diabetes Mellitus
The Impact of Myo-Inositol Supplementation on Glycemic Control and Oxidative Stress in Women With Gestational Diabetes Mellitus: A Randomized, Open-Label Pilot Study
The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM).
The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. In the subsequent 12-14-week study phase, participants will receive a supplement based on random group assignment. They will be allocated either to an intervention group (myo-inositol + folic acid) or a control group (folic acid). Both supplements will be taken until delivery.
The intervention group supplement contains 4 g myo-inositol and 400 μg folic acid (BIOGENA GmbH, Salzburg) and is to be taken twice daily with water - three capsules per meal. The control group supplement contains only 400 μg folic acid (BIOGENA GmbH, Salzburg) and is also taken twice daily, one capsule per meal. As this is a pilot study, both participants and study personnel will be aware of group assignments.
Blood glucose measurements will be repeated mid-study (around the 33rd week of pregnancy) and at the end (37th week of pregnancy) using glucose sensors. To improve the evaluation of glucose measurements, participants will keep dietary logs during these periods.
Three study visits are planned, during which the following assessments will be conducted. To determine the primary outcome, "time in range (TIR)" (time spent within the target glucose range), three glucose sensor measurements will be performed. At each visit, blood samples will be taken to analyze glycemic control parameters (hemoglobin A1c (HbA1c), fasting glucose, fasting insulin, Homeostasis Model Assessment (HOMA-IR), insulin dosage), oxidative stress markers (total antioxidant capacity, malondialdehyde levels), and inflammatory markers (interleukin-6 (IL-6), C-reactive protein (CRP)). Anthropometric measurements (weight gain, blood pressure, pulse) and body composition (Bioelectrical Impedance Analysis) will also be performed.
Additionally, maternal and fetal birth outcomes will be recorded, including cesarean section rates, fetal gestational weight, preterm birth rates, and neonatal hypoglycemia occurrence. To assess participants' well-being and physical activity, questionnaires will be distributed at the beginning and end of the study.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc
- 전화번호: +43 1 404 00-60950
- 이메일: Michael.Leutner@meduniwien.ac.at
연구 연락처 백업
- 이름: Ricarda Rosalia Baron, MSc, Msc
- 전화번호: +43 1 404 00-20690
- 이메일: Ricarda.Baron@meduniwien.ac.at
연구 장소
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State of Vienna
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Vienna, State of Vienna, 오스트리아, 1090
- 모병
- Medical University of Vienna
-
연락하다:
- Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc
- 전화번호: +43 1 404 00-60950
- 이메일: Michael.Leutner@meduniwien.ac.at
-
부수사관:
- Ricarda Rosalia Baron, MSc, MSc
-
Vienna, State of Vienna, 오스트리아, 1090
- 모병
- Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna
-
연락하다:
- Ricarda Rosalia Baron Baron, MSc
- 전화번호: + 43 40400 20690
- 이메일: Ricarda.Baron@meduniwien.ac.at
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- GDM diagnosis
- at least one of the HAPO-Study criteria: 2h-oGTT → >153 mg/dl, 1h-oGGT → >180 mg/dl, fasting plasma glucose > 92 mg/dl
- age between 18-45
- single pregnancy
Exclusion Criteria:
- T2DM
- T1DM
- Maturity Onset Diabetes of the Young (MODY)
- Latent Autoimmune Diabetes in Adults (LADA)
- pre pregnancy BMI >35
- oral antidiabetic drugs
- pre-existing renal disease
- heart disease and other chronic medical disorders
- allergies to any ingredients contained in the dietary supplements
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1. Intervention group (nutrition therapy + myo-inositol + folic acid)
Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the investigational supplement myo-inositol plus folic acid.
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This dietary supplement contains 2 g of myo-inositol and 200 µg folic acid per capsule.
It should be taken twice a day (à 3 capsules) with fluid intake and a meal.
Women with GDM who maintain their blood sugar levels with nutritional therapy.
|
|
실험적: 2. Intervention group (insulin therapy + myo-inositol + folic acid)
Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the investigational supplement myo-inositol plus folic acid.
|
This dietary supplement contains 2 g of myo-inositol and 200 µg folic acid per capsule.
It should be taken twice a day (à 3 capsules) with fluid intake and a meal.
Women with GDM who maintain their blood glucose levels with insulin therapy.
|
|
활성 비교기: 3. Control group (nutrition therapy + folic acid)
Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the supplement folic acid.
|
Women with GDM who maintain their blood sugar levels with nutritional therapy.
This dietary supplement contains 200 μg of folic acid per capsule and should also be taken twice a day (à 1 capsule) with adequate fluid intake and a main meal.
|
|
활성 비교기: 4. Control group (inuslin therapy + folic acid)
Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the supplement folic acid.
|
Women with GDM who maintain their blood glucose levels with insulin therapy.
This dietary supplement contains 200 μg of folic acid per capsule and should also be taken twice a day (à 1 capsule) with adequate fluid intake and a main meal.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time in Range
기간: 10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37
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Time in Range [%] measured with continous glucose monitoring
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10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fasting glucose
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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fasting glucose [mg/dl] concentration
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24.-28. gestational week, 33. gestational week, 37. gestational week
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Fasting insulin
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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fasting insulin [μIU/mL] concentration
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24.-28. gestational week, 33. gestational week, 37. gestational week
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HOMA-IR
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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HOMA-IR calculated as fasting insulin level (micro-units per milliliter) multiplied by the fasting blood glucose level (milligrams per deciliter), dividing the result by 405
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24.-28. gestational week, 33. gestational week, 37. gestational week
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HbA1c
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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HbA1c [%] concentration
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24.-28. gestational week, 33. gestational week, 37. gestational week
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Insulin doses
기간: from day 1 until delivery
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insulin units [IU]
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from day 1 until delivery
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Pre Pregnancy BMI
기간: before pregnancy
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weight [kg]/height [m]^2
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before pregnancy
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Height in meters
기간: at baseline
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height [m]
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at baseline
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Weight in kilograms
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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weight [kg]
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24.-28. gestational week, 33. gestational week, 37. gestational week
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Blood Pressure
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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blood pressure [mmHg]
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24.-28. gestational week, 33. gestational week, 37. gestational week
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C-Section (maternal and fetal outcomes)
기간: at delivery
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C-Section yes or no
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at delivery
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Hypoglycemia of the child (maternal and fetal outcomes)
기간: at delivery
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glucose values of the child [mg/dl]
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at delivery
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Preterm birth (maternal and fetal outcomes)
기간: at delivery
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delivery before 37. gestational week yes or no
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at delivery
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Gestational weight of the child (maternal and fetal outcomes)
기간: at delivery
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gestational weight of the child [kg]
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at delivery
|
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Oxidative stress parameter
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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total antioxidative capacity [µmol/l]
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24.-28. gestational week, 33. gestational week, 37. gestational week
|
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Oxidative stress parameter
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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Malondialdehy status [µmol/l]
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
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Inflammatory parameter
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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C-reactive protein [mg/dl]
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24.-28. gestational week, 33. gestational week, 37. gestational week
|
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Inflammatory parameter
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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interleucin-6 [pg/ml]
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24.-28. gestational week, 33. gestational week, 37. gestational week
|
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Psychometric parameter
기간: 24.-28. gestational week, 37. gestational week
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Questionnaire: Pregnancy-related Anxiety score
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24.-28. gestational week, 37. gestational week
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Psychometric parameter
기간: 24.-28. gestational week, 37. gestational week
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Questionnaire: Postnatal-Depression score
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24.-28. gestational week, 37. gestational week
|
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Psychometric parameter
기간: 24.-28. gestational week, 37. gestational week
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Questionnaire: Perceived Stress score
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24.-28. gestational week, 37. gestational week
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Physical Activity parameter
기간: 24.-28. gestational week, 37. gestational week
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Questionnaire: Physical Activity score [MET] - average daily energy expenditure by calculating the metabolic equivalents (METs) for each activity |
24.-28. gestational week, 37. gestational week
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Nutritional log
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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Food diary for 10 days
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24.-28. gestational week, 33. gestational week, 37. gestational week
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Bioelectrical Impedance Analysis (BIA)
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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fat mass [kg]
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
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Bioelectrical Impedance Analysis (BIA)
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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total body water [%]
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
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Bioelectrical Impedance Analysis (BIA)
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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muscle mass [kg]
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
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Bioelectrical Impedance Analysis (BIA)
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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fat free mass [%]
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
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Bioelectrical Impedance Analysis (BIA)
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
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body cell mass [%]
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
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Bioelectrical Impedance Analysis (BIA)
기간: 24.-28. gestational week, 33. gestational week, 37. gestational week
|
extracellular mass [%]
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2469/2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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