Preventing Diabetic Osteoporosis With Exercise (DIABETICBONE)
Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women
The two specific aims of the study were to determine whether:
- Greater mechanical loading of downhill exercise will increase the osteogenic index (ratio between CICP, the marker of bone formation (c-terminal propeptide of type I collagen, and CTX, the marker of bone resorption (c terminal telopeptide of type I collagen)) to a greater extent than uphill exercise that provides lower ground-reaction force;
- Exercise after the meals will induce greater osteogenic response than exercise pefore the meals as it is known that meal eating during daytime inhibits bvone resorption markers.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Produit combiné: Behavior intervention of uphill exercise
- Produit combiné: Dietary intervention of exercise before the meal
- Produit combiné: Dietary intervention of exercise before the meal
- Produit combiné: Dietary intervention of uphill exercise
- Produit combiné: Dietary intervention of exercise after the meal
- Produit combiné: Dietary intervention of exercise after the meal
- Produit combiné: Behavior intervention of downhill exercise
- Produit combiné: Behavioral intervention of downhill exercise
- Produit combiné: Behavioral intervention of sedentary no-exercise trial
- Produit combiné: Dietary intervention of eating two meals
Description détaillée
The study addresses the problem that postmenopausal women with type 2 diabetes have a higher incidence of bone breaks despite their often normal bone mineral density (BMD).
The investigators pursued two hypotheses, that:
- 40-minute bout of downhill exercise will increase the CICP/CTX osteogenic index to a greater extent than the same amount of uphill exercise; and
- Performing exercise one hour after the meals will be more osteogenic than exercise before the meals.
Subjects were 15 postmenopausal women with type 2 diabetes, age 57.7 years, BMI 27.2 kg/m2 who were randomly assigned to two out of 5 trials:
Uphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), Downhill exercise after the meals (DAM), and Sedentary, no-exercise, trial (SED). All subjects signed an informed consent approved by the University of Michigan Medical School Institutional Review Board. Subjects had their BMD measured with DXA at the outset.
Weight-maintenance meals contained 50% carbohydrate, 15% protein, and 25% fat and were provided at 10 h and 17 h. Exercise (40 minutes at 50% of maximal effort) on either uphill (+6o slope) or downhill treadmill (-6o slope) was performed either before the two meals, at 9 h and 16 h, respectively, or after the meals. at 11 h and 18 h, respectively.
Blood was drawn through an intravenous catheter from ante-cubital vein at hourly intervals between 8 and 20 h with two additional blood draws at 0 h and 6 h the next morning. Blood was treated with protease inhibitors, and plasma, frozen at -80o C, was used to measure bone markers, CICP, CTX, osteocalcin , and bone-specific alkaline phosphatase using Millipore chemoluminescen reagents, glucose by glucose oxidase, and hormones insulin, cortisol, parathyroid hormone (PTH) , and growth hormone (GH) by radio-immunoassays..
Mixed-model ANOVA was used for analysis of outcome measures where the trial procedures served as fixed variable and individual subjects as intercept variables.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
postmenopausal type-2 diabetes melllitus age between 50 and 65 exercise less than 20 minutes three times a week
Exclusion Criteria:
metabolic disease other than type-2 diabetes and hormonally-corrected hypothyroidism musculo-skeletal disability that would preclude exercise smoker do not meet inclusion criteria
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Uphill exercise before the meals
40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal
|
40 minutes of uphill exercise
40 minutes of uphill exercise completed 1 h before the meal
40 minutes of downhill exercise completed 1 hour before the meal
|
|
Expérimental: Uphill exercise after the meals
40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal
|
40 minutes of uphill exercise
40 minutes of uphill exercise started 1 hour after gthe meal
40 minutes of downhill exercise started 1 hour after the meal
|
|
Expérimental: Downhill exercise before the meals
40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal
|
40 minutes of uphill exercise completed 1 h before the meal
40 minutes of downhill exercise completed 1 hour before the meal
40 minutes of downhill exercise
|
|
Expérimental: Downhill exercise after the meals
40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal
|
40 minutes of uphill exercise started 1 hour after gthe meal
40 minutes of downhill exercise started 1 hour after the meal
40 minutes of downhill exercise
|
|
Comparateur factice: Sedentary trial
A trial with no exercise
|
Sedentary no-exercise trial
Meals eaten at 10 and 17 h during a sedentary trial
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
C-terminal propeptide of type I collagen
Délai: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Change over time in plasma concentration of c-terminal propeptde of type 1 collagen (ng/ml)
|
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
|
C-terminal telopeptide of type 1 collagen
Délai: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Change over time in plasma concentration of c-terminal telopeptide of type 1 collagen (ng/ml)
|
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
|
Osteocalcin
Délai: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Change over time in plasma concentration of osteocalcin (ng/ml)
|
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
|
Bone-specific alkaline phosphatase
Délai: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Change over time in plasma concentration of bone-specific alkaline phosphatase (ng/ml)
|
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Insulin
Délai: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Change over time in plasma concentration of insulin (µU/ml)
|
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
|
Parathyroid hormone
Délai: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Change over time in plasma concentration of parathyroid hormone (ng/ml)
|
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
|
Cortisol
Délai: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Change over time in plasma concentration of cortisol (m/L)
|
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
|
Growth hormone
Délai: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Change over time in plasma concentration of growth hormone (ng/ml)
|
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
|
Glucose
Délai: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
Change over time in plasma concentration of glucose (mg/dl)
|
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
|
|
Dual-energy X-ray radiography
Délai: A week prior to the study baseline
|
Whole-body dual-energy X-ray radiography scan
|
A week prior to the study baseline
|
|
Novel Pedar
Délai: During two one-hour bouts of the exercise intervention
|
Mechanosensitive shoe inserts for measurement of ground reaction force
|
During two one-hour bouts of the exercise intervention
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Katarina T Borer, Professor Emerita
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HUM32227/ HUM32700
- R15DK082800 (Subvention/contrat des NIH des États-Unis)
- M01RR024986 (Autre subvention/numéro de financement: Michigan Institute of Clinical and Health Research)
Informations sur les médicaments et les dispositifs, documents d'étude
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