Alimentation and Diabetes in Lanzarote - ADILAN: a Pilot Trial

NCT01891955 | Completed

• 1 other identifier: MFV-ADI-2013-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two healthy diets (according to official Spanish guidelines) that have been shown to be effective in the treatment of type 2 diabetes in order to see if one is better than the other. Another goal is to test the hypothesis that food choice has metabolic effects that are independent of macro/micronutrient composition, fiber content, glycemic load and weight loss in the treatment of type 2 diabetes.

Conditions

Type 2 Diabetes

Keywords

Diabetes mellitus type 2; Cereals; Dairy; Dietary carbohydrates; Dietary fiber; Food; Metabolic syndrome; Satiety

Outcome Measures

Primary Outcomes (2)

• Fasting fructosamine

  Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks

• Fasting glucagon

  Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks

Secondary Outcomes (18)

• Area under the curve for glucose (AUC glucose0-120) at the oral glucose tolerance test

  Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks

• Area under the curve for glucagon (AUC glucagon0-120) at the oral glucose tolerance test

  Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks

• Fasting plasma glucose

  Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks

• Total cholesterol

  Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks

• Low-density lipoprotein (LDL) cholesterol

  Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks

Study Arms (2)

Diet A

ACTIVE COMPARATOR

Healthy diet with grains and dairy

Behavioral: Healthy diet A

Diet B

ACTIVE COMPARATOR

Healthy diet without grains and dairy

Behavioral: Healthy diet B

Interventions

Healthy diet A BEHAVIORAL

Healthy diet A will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet B. Healthy diet A will include substantial amounts of whole grains, low-fat dairy and legumes (this is called "healthy diet with grains and dairy"). This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins.

Diet A

Healthy diet B BEHAVIORAL

Healthy diet B will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet A. Healthy diet B will exclude grains, legumes and dairy, which will largely be replaced by root vegetables, vegetables and fruit, and slightly more lean meat, fish and nuts (this is called "healthy diet without grains and dairy"). Salt intake will be lower in healthy diet B. This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins.

Diet B

Eligibility Criteria

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

You may qualify if:

• Medical diagnosis of type 2 diabetes
• Increased waist circumference (≥80 cm for women and ≥94 cm for men)
• Unaltered medical diabetes treatment since three months before start of study
• Stable weight (varied less than 5%) since three months before start of study
• HbA1c ≥6.0%

You may not qualify if:

• Creatinine \>130 μmol/L
• Change of treatment with betablocker last 3 months
• Change of treatment with thyroid hormone substitution last 3 months
• Treatment with anticoagulant medication
• Oral or injected steroid treatment
• Elevated liver enzymes (AST, ALT, ALP, GPT \> 4 times their respective upper reference value)
• Physical or psychical illness, or changes in personal circumstances that make it impossible for the patient to continue in the study

Sponsors & Collaborators

• Lund University: lead
• Cabildo de Lanzarote: collaborator
• Ayuntamiento de Teguise: collaborator
• Ayuntamiento de Arrecife: collaborator

Study Sites (1)

Hospital Insular de Lanzarote

Arrecife, Las Palmas, 35500, Spain

Location

Related Publications (6)

• Nield L, Moore HJ, Hooper L, Cruickshank JK, Vyas A, Whittaker V, Summerbell CD. Dietary advice for treatment of type 2 diabetes mellitus in adults. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD004097. doi: 10.1002/14651858.CD004097.pub4.

  PMID: 17636747 BACKGROUND

• Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013 Mar;97(3):505-16. doi: 10.3945/ajcn.112.042457. Epub 2013 Jan 30.

  PMID: 23364002 BACKGROUND

• Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.

  PMID: 19604407 BACKGROUND

• Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.

  PMID: 17583796 BACKGROUND

• Jonsson T, Olsson S, Ahren B, Bog-Hansen TC, Dole A, Lindeberg S. Agrarian diet and diseases of affluence--do evolutionary novel dietary lectins cause leptin resistance? BMC Endocr Disord. 2005 Dec 10;5:10. doi: 10.1186/1472-6823-5-10.

  PMID: 16336696 BACKGROUND

• Fontes-Villalba M, Jonsson T, Granfeldt Y, Frassetto LA, Sundquist J, Sundquist K, Carrera-Bastos P, Fika-Hernando M, Picazo O, Lindeberg S. A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study--Alimentation and Diabetes in Lanzarote--ADILAN. Trials. 2014 Jan 2;15:2. doi: 10.1186/1745-6215-15-2.

  PMID: 24383431 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 3, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 21, 2014

Record last verified: 2014-03

Locations

ES (1)