Effect of the CAIPaDi Care Model in Relatives of Patients With Type 2 Diabetes Mellitus

NCT03234946 | Unknown DMC

• 1 other identifier: 2145
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

Brief Summary

Diabetes is a chronic disease that requires long-term lifestyle changes that may affect the whole family. Hence, during the last decade, studies have focused mainly in the role of the members of the family and their influence in life quality or clinical outcomes of patients with diabetes. Therefore, the delivery of education only to the patients with type 2 diabetes mellitus may restrict the expectations of success in achieving the necessary modifications in lifestyle. Objectives: To assess the effect of the CAIPaDi (Centre of Comprehensive Care for the Patients with Diabetes) program interventions on various health indicators relatives of patients with type 2 diabetes mellitus.

Conditions

Metabolic Syndrome

Keywords

Diabetes; Family; Impaired fasting-glucose; Carbohydrate intolerance

Outcome Measures

Primary Outcomes (2)

• Glycated hemoglobin

  60% of patients with a glycated hemoglobin of \<5.8

  1 year

• Body Mass Index

  Difference of 2kg/m2 between groups

  1 year

Secondary Outcomes (9)

• Serum glucose

  1 year

• Non-HDL cholesterol

  1 year

• Triglycerides

  1 year

• Blood pressure

  1 year

• Weight loss

  1 year

Study Arms (2)

Group A

NO INTERVENTION

Relatives of patients with diabetes who will only attend sessions at the center along with the patients on all the interventions of the center (except psychology and psychiatry), receiving instructions from each area on the first and fourth visit. When the patient with diabetes is in the psychology or psychiatry consultation, the relative will also be evaluated in these areas in an analogue form.

Group B

EXPERIMENTAL

Relatives who will receive multidisciplinary care at the center The subjects from group B will be asked to be accompanied by another relative. If they accept, they will be included as a patient of the CAIPaDi program to receive all the interventions of the second, third and fourth visits in an individual form, without following the patient with diabetes.

Behavioral: CAIPaDi

Interventions

CAIPaDi BEHAVIORAL

Patients are attended in 1 day by 9 specialists (endocrinologist, diabetes educators, nutritionist, psychologist, physical activity specialist, foot care and ophthalmologist). They are attended in 4 monthly visits. After the initial phase, patients come back to the Center at 1 and 2 years for evaluation and reinforcement

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a relative of a patient of CAIPaDi
• Fasting glucose of \<125 mg/dl
• Serum glucose of \<199 mg/dl 2 hours after a glucose load of 75 gr

You may not qualify if:

• Diagnosis of diabetes
• Smoking
• Who has any disabling or priority health condition other than prevention of diabetes

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Mexican National Institute of Public Health: collaborator

Study Sites (2)

Instituto Nacional de Salud Pública

Cuernavaca, Morelos, 62100, Mexico

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14000, Mexico

Location

Related Publications (16)

• Villalpando S, Shamah-Levy T, Rojas R, Aguilar-Salinas CA. Trends for type 2 diabetes and other cardiovascular risk factors in Mexico from 1993-2006. Salud Publica Mex. 2010;52 Suppl 1:S72-9. doi: 10.1590/s0036-36342010000700011.

  PMID: 20585732 BACKGROUND

• Aguilar Salinas CA, Gómez Diaz RA, Gomez Perez FJ. Type 2 diabetes in Mexico: Main Challenges and possible solutions. Revista ALAD 19(4): 146-161, 2011.

  BACKGROUND

• Schinckus L, Van den Broucke S, Housiaux M; Diabetes Literacy Consortium. Assessment of implementation fidelity in diabetes self-management education programs: a systematic review. Patient Educ Couns. 2014 Jul;96(1):13-21. doi: 10.1016/j.pec.2014.04.002. Epub 2014 Apr 21.

  PMID: 24795074 BACKGROUND

• Machado Bonfante H, da Costa Avila M, Miranda Marcon L, Andrade Pedrosa C, de Oliveira Goncalves Prince Soares H, Fonseca Reis L, Pereira Mendonca U, dos Reis Barreiros A, Porto Araújo de Andrade M. Prediabetes: Clinical Relevance of an Important Risk Marker. Revista Brasileira de Cièncias Médicas e da Saúde 3(3):1-5, 2015.

  BACKGROUND

• Perez Siwik V, Kutob RM, Ritenbaugh C, Aickin M, Gordon JS. Families United/Familias Unidas: development and implementation of a family-based group office visit model for the primary prevention of type 2 diabetes. Diabetes Educ. 2012 Nov-Dec;38(6):811-21. doi: 10.1177/0145721712461533. Epub 2012 Sep 26.

  PMID: 23019237 BACKGROUND

• Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.

  PMID: 12453955 BACKGROUND

• Lindstrom J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003 Dec;26(12):3230-6. doi: 10.2337/diacare.26.12.3230.

  PMID: 14633807 BACKGROUND

• Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.

  PMID: 9096977 BACKGROUND

• Hariri S, Yoon PW, Qureshi N, Valdez R, Scheuner MT, Khoury MJ. Family history of type 2 diabetes: a population-based screening tool for prevention? Genet Med. 2006 Feb;8(2):102-8. doi: 10.1097/01.gim.0000200949.52795.df.

  PMID: 16481893 BACKGROUND

• Kovacs Burns K, Holt RI, Nicolucci A, Lucisano G, Skovlund SE, Comaschi M, Vallis M, Peyrot M. Correlates of psychological outcomes among family members of people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2() ) study. Diabet Med. 2016 Sep;33(9):1184-93. doi: 10.1111/dme.13136. Epub 2016 May 26.

  PMID: 27086909 BACKGROUND

• Shi M, Xu MY, Liu ZL, Duan XY, Zhu YB, Shi HM, Jiang B, Zhang XM, Yu XH. Effectiveness of family involvement in newly diagnosed type 2 diabetes patients: a follow-up study. Patient Educ Couns. 2016 May;99(5):776-82. doi: 10.1016/j.pec.2015.12.018. Epub 2015 Dec 30.

  PMID: 26763869 BACKGROUND

• Arslanian SA, Bacha F, Saad R, Gungor N. Family history of type 2 diabetes is associated with decreased insulin sensitivity and an impaired balance between insulin sensitivity and insulin secretion in white youth. Diabetes Care. 2005 Jan;28(1):115-9. doi: 10.2337/diacare.28.1.115.

  PMID: 15616243 BACKGROUND

• Herman WH, Hoerger TJ, Brandle M, Hicks K, Sorensen S, Zhang P, Hamman RF, Ackermann RT, Engelgau MM, Ratner RE; Diabetes Prevention Program Research Group. The cost-effectiveness of lifestyle modification or metformin in preventing type 2 diabetes in adults with impaired glucose tolerance. Ann Intern Med. 2005 Mar 1;142(5):323-32. doi: 10.7326/0003-4819-142-5-200503010-00007.

  PMID: 15738451 BACKGROUND

• Hu J, Wallace DC, McCoy TP, Amirehsani KA. A family-based diabetes intervention for Hispanic adults and their family members. Diabetes Educ. 2014 Jan-Feb;40(1):48-59. doi: 10.1177/0145721713512682. Epub 2013 Nov 18.

  PMID: 24248832 BACKGROUND

• Mayberry LS, Harper KJ, Osborn CY. Family behaviors and type 2 diabetes: What to target and how to address in interventions for adults with low socioeconomic status. Chronic Illn. 2016 Sep;12(3):199-215. doi: 10.1177/1742395316644303. Epub 2016 Apr 19.

  PMID: 27099387 BACKGROUND

• Kutob RM, Siwik VP, Aickin M, Ritenbaugh C. Families United/Familias Unidas: family group office visits to reduce risk factors for type 2 diabetes. Diabetes Educ. 2014 Mar-Apr;40(2):191-201. doi: 10.1177/0145721714520722. Epub 2014 Jan 24.

  PMID: 24464087 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus; Glucose-Galactose Malabsorption

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ana C García Ulloa, MD

  Grade A Specialized Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Relatives of CAIPaDi patients that present on their initial evaluation either overweight, obesity, hypertension, glucose intolerance and/or secondary dyslipidemia will be invited to participate. Those who accept will require to attend the center twice. On the first visit, an anthropometric evaluation and laboratory studies will be performed; an oral glucose tolerance (OGTT) test will be carried out if the glucose value is over 100 mg/dl. If the OGTT results are abnormal, the individual will be included in the study sample. Those who have an abnormal OGTT and are included in the study sample will be randomized into two groups. The change of the main variables (weight, waist circumference, serum glucose, glycated hemoglobin, blood pressure, triglycerides and non-HDL cholesterol) will be assessed 3 months later, along with the effect on patients with diabetes parameters.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: June 19, 2017
• Primary Completion: June 19, 2021
• Study Completion: June 19, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

ME (2)