Women With Previous GDM and the Effects of HIIT.

Официальное название

Deep Metabolic and Molecular Phenotyping of Women With Previous Gestational Diabetes Mellitus and the Responses to High-intensity Interval Training.

Обзор

The goal of this clinical trial is to investigate if women with previous gestational diabetes (pGDM) are characterized with unique metabolic and molecular alterations compared to women without pGDM. Furthermore if 8 weeks of high-intensity interval training (HIIT) can improve these alterations. The main questions we aim to answer are: 1. Women with pGDM have metabolic abnormalities compared with women without pGDM, and that these metabolic abnormalities are explained by unique molecular abnormalities in skeletal muscle and adipose tissue. 2. Eight weeks of HIIT combining rowing and cycling can markedly improve these metabolic abnormalities in women with pGDM and these improvements are explained by beneficial cellular and molecular changes in skeletal muscle and adipose tissue. Researchers will compare 20 women with pGDM to 20 glucosetolerant without pGDM, who are matched on age, BMI and times since last pregnancy. Participants will undergo a screening visit and examinations on two separate days before (day 1 and day 2) and two separate days after (day 3 and day 4) 8-weeks of HIIT, in all cases after an overnight fast (≥ 12 h). Day 1 and day 3 will include assessment of body composition and VO2max. On day 2 and day 4, the insulin sensitivity, substrate metabolism, and β-cell function of the participants will be examined by a Botnia-clamp combined by indirect calorimetry. Skeletal muscle biopsies from m. vastus lateralis and subcutaneous abdominal adipose tissue biopsies are taken in the basal and insulin-stimulated states of each clamp.

Вмешательства

• Другое High-intensity interval training
  The training intervention consists of 8-weeks of HIIT combining rowing and cycling on ergometers with two supervised sessions weekly in small groups of up to 10 participants. All HIIT sessions will start with a 10-min warm-up period followed by training blocks of 5 x 1 min high-intensity intervals (100-110% of Wattmax corresponding to ≥ 85% of maximum heart rate (HRmax)) each interspersed by 1 min active or resting recovery. Between the training blocks, the participants will have a 4-min break i

Первичные конечные точки

• β-cell function by OGTT [Срок оценки: At screening visit.]
• β-cell function by Botnia-clamp [Срок оценки: At examination day 2 and 4.]
• Whole body composition (lean body mass and fat mass) [Срок оценки: At examination day 1 and 3.]
• Lean body mass [Срок оценки: At examination day 1 and 3.]
• Fat mass [Срок оценки: At examination day 1 and 3.]
• Cardiorespiratory fitness (maximal oxygen consumptions (VO2-max)) [Срок оценки: At examination day 1 and 3.]
• Insulin sensitivity by Botnia-clamp [Срок оценки: At examination day 2 and 4.]

Вторичные конечные точки (11)

• Plasma-specific metabolomics by LC- and GC-MS [Срок оценки: At examination day 2 and 4.]
• Tissue-specific metabolomics by LC- and GC-MS [Срок оценки: At examination day 2 and 4.]
• Proteomics [Срок оценки: At examination day 2 and 4.]
• Phosphoproteomics [Срок оценки: At examination day 2 and 4.]
• Transcriptional profiling and gene expression [Срок оценки: At examination day 2 and 4.]
• Mitochondrial respiration [Срок оценки: At examination day 2 and 4.]
• Lipid droplets by TEM [Срок оценки: At examination day 2 and 4.]
• Mitochondria by TEM [Срок оценки: At examination day 2 and 4.]
• Lipid droplet interaction with mitochondria by TEM [Срок оценки: At examination day 2 and 4.]
• Protein abundance [Срок оценки: At examination day 2 and 4.]
• Phosphorylation of enzymes [Срок оценки: At examination day 2 and 4.]

Критерии участия

Критерии включения

• Age 25-45 years
• BMI 20-35 kg/m2
• 2-8 years since the last pregnancy
• No known diabetes or PCOS
• No previous bariatric surgery
• No known disease
• Be drug-naive
• Have a regular menstrual cycle (23-35 days)
• Not be pregnant or planning pregnancy during the study period
• Low or moderate level of physical activity must be (max 2 hours of moderate exercise weekly).
• All participants should be able to provide informed consent
• Women without pGDM must not have known hypertension or first-degree relatives with diabetes.

Критерии исключения

• Abnormal cardiac stethoscopy, ECG or screening blood tests
• Positive plasma GAD-65 antibodies
• Positive plasma choriogonadotropine
• Undiagnosed T2D based on fasting plasma glucose (≥ 7.0 mmol/mol), plasma HbA1c (≥ 48 mmol/mol), or 2-h plasma glucose during an oral glucose tolerance test (OGTT) (≥ 11.1 mmol/mol)
• Dyslipidemia (plasma LDL-cholesterol > 5.0 mmol/l)
• In women with pGDM: Undiagnosed severe hypertension (blood pressure > 160/100)
• In women without pGDM: Undiagnosed hypertension (blood pressure >140/90 mmHg) or impaired glucose tolerance (fasting plasma glucose at 6.16.9 mmol/l, plasma HbA1c at 42-47 mmol/mol, or a 2-h glucose at 7.8-11.0 mmol/l during an OGTT).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Дания · 1 центр

• Steno Diabetes Center Odense, Odense University Hospital — Odense

Идентификаторы

NCT: NCT07566845 · 25/55674

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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