N/A
N=122
Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes
Prediabetes
Bottom Line
View on ClinicalTrials.gov: NCT02635646 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Individual Insulin Resistance and Insulin Secretion — 4.9; 4.8 score on a scale — p=0.844
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Family and interdisciplinary approach (Other); individual approach (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad de Guanajuato
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Individual Insulin Resistance and Insulin Secretion |
4.7; 4.9 | 0.624 |
| PRIMARY Individual Insulin Resistance and Insulin Secretion |
4.7; 4.9 | 0.624 |
| SECONDARY Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients) |
5.5; 4.6 | <0.05 sig |
| SECONDARY Weight |
65.4; 75.0 | 0.516 |
| SECONDARY 2h OGTT Glucose |
135; 131; 142; 127 | <0.05 sig |
Summary
The purpose of the study is to evaluate the effect of a family and interdisciplinary approach on individual and family insulin resistance and insulin secretion in patients with prediabetes.
Eligibility Criteria
Inclusion Criteria
- Patients with prediabetes (Fasting glucose 100-125mg/dl and/or 2h post OGTT glucose 140-199mg/dl)
- Family of patients with prediabetes (in case of the patients that are randomized to FAMILY APPROACH)
- Signing of the inform consent
Exclusion Criteria
- Type 2 diabetes
- Pregnancy
- Liver disease
- Renal disease
Data sourced from ClinicalTrials.gov (NCT02635646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.